Generated Narrative: ResearchStudy 583768 version: 2; Last updated: 2026-07-27 13:49:52+0000 Profile: StudyRegistryRecord ArtifactPublicationStatus: Active Artifact Author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: url: https://fevir.net/resources/ResearchStudy/583768 identifier: FEvIR Object Identifier/583768, <a href="http://terminology.hl7.org/7.3.0/NamingSystem-ClinicalTrials-Gov.html" title="The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed [ClinicalTrials.gov](http://clinicaltrials.gov) to provide patients, family members, and members of the public current information about clinical research studies. [ClinicalTrials.gov](http://clinicaltrials.gov) contains summary information about clinical studies being conducted throughout the United States and in many countries throughout the world. These data are provided to the National Library of Medicine by organizations and institutions that sponsor and implement the studies.#xD;#xA;#xD;#xA;[ClinicalTrials.gov](http://clinicaltrials.gov) is updated daily. You should check [ClinicalTrials.gov](http://clinicaltrials.gov) frequently for updated information.#xD;#xA;#xD;#xA;More information about ClinicalTrials.gov can be found [here](https://clinicaltrials.gov/about-site/about-ctg).">ClinicalTrials.gov/NCT05327010 (use: official, ), NCI-2022-02915, Registry Identifier/NCI-2022-02915, NCI10486, Other Identifier/10486, Other Identifier/10486, U.S. NIH Grant/Contract/UM1CA186688, FEvIR Linking Identifier/NCT05327010 FHIR Transform name: NCT05327010_FHIR_Transform title: Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial Labels - Type Value * Official title Phase 2 Trial of the Combination of the BET Inhibitor, ZEN003694 (ZEN-3694), and the PARP Inhibitor Talazoparib, in Patients With Molecularly-Selected Solid Tumors (ComBET) citeAs: Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial [Database Entry: FHIR ResearchStudy Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 583768. Revised 2026-07-27. Available at: https://fevir.net/resources/ResearchStudy/583768. Computable resource at: https://fevir.net/resources/ResearchStudy/583768#json. relatesTo type: Transforms target: https://clinicaltrials.gov/api/v2/studies/NCT05327010?format=json relatesTo type: Transformed With target: null @ https://fevir.net/ctgovconvert relatesTo type: Supported With target: null @ https://reporter.nih.gov/quickSearch/UM1CA186688 relatesTo type: Supported With target: null @ https://grants.nih.gov/policy/sharing.htm status: Active phase: Phase 2 studyDesign: Design Masking: None (Open Label), Design Allocation: NA, Uncontrolled cohort design, interventional research condition: Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm descriptionSummary: This phase II trial tests whether ZEN003694 (ZEN-3694) in combination with talazoparib works to shrink tumors in patients with solid tumors that are unlikely to be cured or controlled with treatment and that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Another aim of this study is to find out if, and how, patients' genes influence their response to this specific drug combination. For this part of the study, investigators will run tests using samples of patients' tumor tissue and blood that will be collected during the study. ZEN-3694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that overproduce BET protein. Talazoparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Genes are pieces of the DNA code that individuals inherit from their parents. Some genes work to protect against cancer by correcting damage that can occur in the DNA when cells divide. BRCA1 and BRCA2 are two examples of these types of genes, and they are called tumor-suppressor genes. For example, if a person has a mutation in a BRCA1/2 gene they have a greatly increased risk of developing breast and ovarian cancer because their cells may no longer be able to completely repair damaged DNA. It is the accumulation of DNA damage which causes a cell to change into a cancerous cell. Other genes are also involved in this process, and these are called DNA damage repair genes. The KRAS mutation is a change in a protein in normal cells. Normally KRAS serves as an information hub for signals in the cell that lead to cell growth, but when there is a mutation in KRAS it signals too much and cells grow without being told to, which causes cancer. Combination therapy with ZEN-3694 and talazoparib may be effective at slowing or stopping tumor growth in patients with advanced cancer. description: PRIMARY OBJECTIVE: I. To evaluate clinical response to the combination of BET bromodomain inhibitor ZEN-3694 (ZEN003694 [ZEN-3694]) and talazoparib using objective response rate (ORR) = (complete response [CR] + partial response [PR]). SECONDARY OBJECTIVES: I. To confirm the safety and toxicity profile of the combination of ZEN003694 (ZEN-3694) and talazoparib. II. To evaluate the clinical benefit rate (stable disease [SD] > 6 months [m]+CR+PR) and progression-free survival (PFS). III. To assess the pharmacodynamics of the combination of ZEN003694 (ZEN-3694) and talazoparib using pre- and on-treatment tumor biopsies. IV. To characterize pharmacodynamic changes of exploratory biomarkers to the combination of ZEN003694 (ZEN-3694) and talazoparib in pre- and on-treatment tumor biopsies. V. To assess putative predictive biomarkers of response and resistance to the combination of ZEN003694 (ZEN-3694) and talazoparib. OUTLINE: Patients receive ZEN-3694 orally (PO) once daily (QD) and talazoparib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo diagnostic imaging, blood sample collection, and tumor biopsy throughout the study. After completion of study treatment, patients are followed up 30 days after administration of the last dose of study drug and then every 3 months for up to 2 years. site: ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active ResearchStudy: status = active classifier: IPDSharing: Yes, IPDSharingDescription: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page., Does not include healthy volunteers, Includes female subjects, Includes male subjects, Minimum Age: 18 Years, Age Group: Adult, Age Group: Older Adult, Has Results: False, Oversight Classifier: oversightHasDmc False, Oversight Classifier: isFdaRegulatedDrug True, Oversight Classifier: isFdaRegulatedDevice False associatedParty name: National Cancer Institute (NCI) role: Sponsor classifier: NIH associatedParty name: National Cancer Institute (NCI) role: Lead sponsor classifier: NIH associatedParty name: Timothy A Yap role: Principal investigator party: University of Texas MD Anderson Cancer Center LAO progressStatus state: Recruiting progressStatus state: Registration submission actual: true period: 2022-04-13 --> (ongoing) progressStatus state: Registration submission Quality Check actual: true period: 2022-04-13 --> (ongoing) progressStatus state: Record Verification actual: true period: ?? --> 2026-07 progressStatus state: Update submission actual: true period: ?? --> 2026-07-17 progressStatus state: Registration posting actual: true period: 2022-04-14 --> (ongoing) progressStatus state: Primary outcome data collection actual: false period: ?? --> 2026-12-31 progressStatus state: Update posting actual: true period: ?? --> 2026-07-20 progressStatus state: Overall study actual: true period: 2022-11-14 --> (ongoing) progressStatus state: Overall study actual: false period: ?? --> 2027-12-31 Recruitments - TargetNumber Eligibility * 88 NCT05327010 Eligibility Criteria ComparisonGroups - Eligibility * Treatment (ZEN-3694, talazoparib) objective type: Primary OutcomeMeasures - Name Type Description Endpoint * Objective response rate (ORR) Primary Systemically assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR = complete response + partial response. Complete response is defined as the disappearance of all target or non-target lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters of target or non-target lesions. Objective response rate (ORR) objective type: Secondary outcomeMeasure name: Duration of response type: Secondary description: Assessed using RECIST v1.1. endpoint: Duration of response outcomeMeasure name: Clinical benefit rate (CBR) type: Secondary description: Assessed by radiographic disease assessments per RECIST v1.1. CBR = overall response + stable disease > 6 months. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. endpoint: Clinical benefit rate (CBR) outcomeMeasure name: Progression-free survival type: Secondary description: Assessed by radiographic disease assessments per RECIST v1.1. endpoint: Progression-free survival outcomeMeasure name: Overall survival type: Secondary description: Assessed by radiographic disease assessments per RECIST v1.1. endpoint: Overall survival outcomeMeasure name: Incidence of adverse events type: Secondary description: Incidence and severity of adverse events and serious adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Includes significant changes in laboratory parameters, electrocardiograms, and vital signs. Summarized by grade and type. endpoint: Incidence of adverse events objective type: Exploratory outcomeMeasure name: Treatment-induced changes in phospho-protein signaling type: Exploratory description: Reverse phase proteomic array in pre- and on-treatment tumor biopsy samples conducted to assess treatment-induced changes in phospho-protein signaling, to correlate with treatment response and progression, and to assess changes in the levels of cytotoxic T lymphocyte precursor. endpoint: Treatment-induced changes in phospho-protein signaling outcomeMeasure name: Correlation of single nucleotide variant (SNV) and copy number variant (CNV) profiles with treatment response type: Exploratory description: Whole exome sequencing conducted on pre-treatment biopsy and at progression to correlate SNV and CNV profiles with treatment response. endpoint: Correlation of single nucleotide variant (SNV) and copy number variant (CNV) profiles with treatment response outcomeMeasure name: Gene expression profiling type: Exploratory description: Ribonucleic acid (RNA) sequencing conducted for gene expression profiling. endpoint: Gene expression profiling outcomeMeasure name: Correlate mutation profiles with tumor sequencing type: Exploratory description: Using circulating tumor deoxyribonucleic acid (ctDNA) for correlation. endpoint: Correlate mutation profiles with tumor sequencing outcomeMeasure name: Correlate baseline mutations with treatment response type: Exploratory description: Using ctDNA for correlation. endpoint: Correlate baseline mutations with treatment response outcomeMeasure name: Correlate changes in ctDNA variant allele frequencies with response type: Exploratory description: Using ctDNA for correlation. endpoint: Correlate changes in ctDNA variant allele frequencies with response outcomeMeasure name: Assess emergent resistant mutations type: Exploratory description: Includes BRCA reversion. endpoint: Assess emergent resistant mutations outcomeMeasure name: Analysis of formalin-fixed paraffin-embedded and blood and blood samples type: Exploratory description: DNA, RNA, and protein analysis conducted. endpoint: Analysis of formalin-fixed paraffin-embedded and blood and blood samples Generated Narrative: EvidenceVariable #NCT05327010-drug------bet-bromodomain-inhibitor-zen-3694 Profile: VariableDefinition EvidenceVariableHandlingDetail: boolean variable name: NCT05327010_drug______bet_bromodomain_inhibitor_zen_3694 title: BET Bromodomain Inhibitor ZEN-3694 status: Active description: Given PO note: , , , suggested alternative name: BETi ZEN-3694 suggested alternative name: ZEN 3694 suggested alternative name: ZEN-3694 suggested alternative name: ZEN003694 handling: STATO:0000724 classifier: Intervention Type: DRUG Generated Narrative: EvidenceVariable #NCT05327010-procedure------biopsy-procedure Profile: VariableDefinition EvidenceVariableHandlingDetail: boolean variable name: NCT05327010_procedure______biopsy_procedure title: Biopsy Procedure status: Active description: Undergo tumor biopsy note: , , suggested alternative name: Biopsy suggested alternative name: BIOPSY_TYPE suggested alternative name: Bx handling: STATO:0000724 classifier: Intervention Type: PROCEDURE Generated Narrative: EvidenceVariable #NCT05327010-procedure------biospecimen-collection Profile: VariableDefinition EvidenceVariableHandlingDetail: boolean variable name: NCT05327010_procedure______biospecimen_collection title: Biospecimen Collection status: Active description: Undergo blood sample collection note: , , , suggested alternative name: Biological Sample Collection suggested alternative name: Biospecimen Collected suggested alternative name: Sample Collection suggested alternative name: Specimen Collection handling: STATO:0000724 classifier: Intervention Type: PROCEDURE Generated Narrative: EvidenceVariable #NCT05327010-procedure------diagnostic-imaging-testing Profile: VariableDefinition EvidenceVariableHandlingDetail: boolean variable name: NCT05327010_procedure______diagnostic_imaging_testing title: Diagnostic Imaging Testing status: Active description: Undergo diagnostic imaging note: , suggested alternative name: Diagnostic Imaging suggested alternative name: Medical Imaging handling: STATO:0000724 classifier: Intervention Type: PROCEDURE Generated Narrative: EvidenceVariable #NCT05327010-drug------talazoparib Profile: VariableDefinition EvidenceVariableHandlingDetail: boolean variable name: NCT05327010_drug______talazoparib title: Talazoparib status: Active description: Given PO note: , , suggested alternative name: BMN 673 suggested alternative name: BMN-673 suggested alternative name: BMN673 handling: STATO:0000724 classifier: Intervention Type: DRUG Generated Narrative: Group #NCT05327010-comparison-group-0 Artifact Author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: identifier: FEvIR Linking Identifier/NCT05327010-comparison-group-0 title: NCT05327010 Comparison Group: Treatment (ZEN-3694, talazoparib) status: Active description: Patients receive ZEN-3694 PO QD and talazoparib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo diagnostic imaging, blood sample collection, and tumor biopsy throughout the study. membership: Conceptual code: Experimental combinationMethod: All of characteristic code: Exposed to value: Drug: BET Bromodomain Inhibitor ZEN-3694 exclude: false characteristic code: Exposed to value: Procedure: Biopsy Procedure exclude: false characteristic code: Exposed to value: Procedure: Biospecimen Collection exclude: false characteristic code: Exposed to value: Procedure: Diagnostic Imaging Testing exclude: false characteristic code: Exposed to value: Drug: Talazoparib exclude: false Generated Narrative: ResearchStudy #NCT05327010-Location-0-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location City of Hope Comprehensive Cancer Center ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-0 name: City of Hope Comprehensive Cancer Center Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 800-826-4673, becomingapatient@coh.org * Principal investigator Irene M. Kang address: Duarte California 91010 United States Positions - Longitude Latitude * -117.97729 34.13945 Generated Narrative: ResearchStudy #NCT05327010-Location-1-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location City of Hope at Irvine Lennar ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-1 name: City of Hope at Irvine Lennar Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 877-467-3411 * Principal investigator Irene M. Kang address: Irvine California 92618 United States Positions - Longitude Latitude * -117.82311 33.66946 Generated Narrative: ResearchStudy #NCT05327010-Location-2-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location UC San Diego Moores Cancer Center ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-2 name: UC San Diego Moores Cancer Center Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 858-822-5354, cancercto@ucsd.edu * Principal investigator Rana R. McKay address: La Jolla California 92093 United States Positions - Longitude Latitude * -117.2742 32.84727 Generated Narrative: ResearchStudy #NCT05327010-Location-3-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location Keck Medicine of USC Koreatown ProgressStatuses - State * Active, not recruiting Generated Narrative: Location #NCT05327010-Location-3 name: Keck Medicine of USC Koreatown address: Los Angeles California 90020 United States Positions - Longitude Latitude * -118.24368 34.05223 Generated Narrative: ResearchStudy #NCT05327010-Location-4-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location Los Angeles General Medical Center ProgressStatuses - State * Active, not recruiting Generated Narrative: Location #NCT05327010-Location-4 name: Los Angeles General Medical Center address: Los Angeles California 90033 United States Positions - Longitude Latitude * -118.24368 34.05223 Generated Narrative: ResearchStudy #NCT05327010-Location-5-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location USC / Norris Comprehensive Cancer Center ProgressStatuses - State * Active, not recruiting Generated Narrative: Location #NCT05327010-Location-5 name: USC / Norris Comprehensive Cancer Center address: Los Angeles California 90033 United States Positions - Longitude Latitude * -118.24368 34.05223 Generated Narrative: ResearchStudy #NCT05327010-Location-6-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location USC Norris Oncology/Hematology-Newport Beach ProgressStatuses - State * Active, not recruiting Generated Narrative: Location #NCT05327010-Location-6 name: USC Norris Oncology/Hematology-Newport Beach address: Newport Beach California 92663 United States Positions - Longitude Latitude * -117.92895 33.61891 Generated Narrative: ResearchStudy #NCT05327010-Location-7-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location University of California Davis Comprehensive Cancer Center ProgressStatuses - State * Active, not recruiting Generated Narrative: Location #NCT05327010-Location-7 name: University of California Davis Comprehensive Cancer Center address: Sacramento California 95817 United States Positions - Longitude Latitude * -121.4944 38.58157 Generated Narrative: ResearchStudy #NCT05327010-Location-8-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location UC San Diego Medical Center - Hillcrest ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-8 name: UC San Diego Medical Center - Hillcrest Contacts - Purpose Name Telecom * General contact Site Public Contact rhabbaba@health.ucsd.edu * Principal investigator Rana R. McKay address: San Diego California 92103 United States Positions - Longitude Latitude * -117.16472 32.71571 Generated Narrative: ResearchStudy #NCT05327010-Location-9-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location UCHealth University of Colorado Hospital ProgressStatuses - State * Active, not recruiting Generated Narrative: Location #NCT05327010-Location-9 name: UCHealth University of Colorado Hospital address: Aurora Colorado 80045 United States Positions - Longitude Latitude * -104.83192 39.72943 Generated Narrative: ResearchStudy #NCT05327010-Location-10-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location Yale University ProgressStatuses - State * Active, not recruiting Generated Narrative: Location #NCT05327010-Location-10 name: Yale University address: New Haven Connecticut 06520 United States Positions - Longitude Latitude * -72.92816 41.30815 Generated Narrative: ResearchStudy #NCT05327010-Location-11-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location Smilow Cancer Hospital Care Center-Trumbull ProgressStatuses - State * Active, not recruiting Generated Narrative: Location #NCT05327010-Location-11 name: Smilow Cancer Hospital Care Center-Trumbull address: Trumbull Connecticut 06611 United States Positions - Longitude Latitude * -73.20067 41.24287 Generated Narrative: ResearchStudy #NCT05327010-Location-12-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location UF Health Cancer Institute - Gainesville ProgressStatuses - State * Active, not recruiting Generated Narrative: Location #NCT05327010-Location-12 name: UF Health Cancer Institute - Gainesville address: Gainesville Florida 32610 United States Positions - Longitude Latitude * -82.32483 29.65163 Generated Narrative: ResearchStudy #NCT05327010-Location-13-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location Emory University Hospital/Winship Cancer Institute ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-13 name: Emory University Hospital/Winship Cancer Institute Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 404-778-1868 * Principal investigator Ticiana A. Leal address: Atlanta Georgia 30322 United States Positions - Longitude Latitude * -84.38798 33.749 Generated Narrative: ResearchStudy #NCT05327010-Location-14-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location Northwestern University ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-14 name: Northwestern University Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 312-695-1301, cancer@northwestern.edu * Principal investigator Aparna Kalyan address: Chicago Illinois 60611 United States Positions - Longitude Latitude * -87.65005 41.85003 Generated Narrative: ResearchStudy #NCT05327010-Location-15-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location University of Kansas Clinical Research Center ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-15 name: University of Kansas Clinical Research Center Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 913-588-3671, KUCC_Navigation@kumc.edu * Principal investigator Joaquina C. Baranda address: Fairway Kansas 66205 United States Positions - Longitude Latitude * -94.6319 39.02223 Generated Narrative: ResearchStudy #NCT05327010-Location-16-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location University of Kansas Cancer Center ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-16 name: University of Kansas Cancer Center Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 913-588-3671, KUCC_Navigation@kumc.edu * Principal investigator Joaquina C. Baranda address: Kansas City Kansas 66160 United States Positions - Longitude Latitude * -94.62746 39.11417 Generated Narrative: ResearchStudy #NCT05327010-Location-17-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location University of Kansas Cancer Center-Overland Park ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-17 name: University of Kansas Cancer Center-Overland Park Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 913-588-3671, KUCC_Navigation@kumc.edu * Principal investigator Joaquina C. Baranda address: Overland Park Kansas 66210 United States Positions - Longitude Latitude * -94.67079 38.98223 Generated Narrative: ResearchStudy #NCT05327010-Location-18-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location University of Kansas Hospital-Indian Creek Campus ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-18 name: University of Kansas Hospital-Indian Creek Campus Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 913-588-3671, KUCC_Navigation@kumc.edu * Principal investigator Joaquina C. Baranda address: Overland Park Kansas 66211 United States Positions - Longitude Latitude * -94.67079 38.98223 Generated Narrative: ResearchStudy #NCT05327010-Location-19-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location University of Kansas Hospital-Westwood Cancer Center ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-19 name: University of Kansas Hospital-Westwood Cancer Center Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 913-588-3671, KUCC_Navigation@kumc.edu * Principal investigator Joaquina C. Baranda address: Westwood Kansas 66205 United States Positions - Longitude Latitude * -94.6169 39.04056 Generated Narrative: ResearchStudy #NCT05327010-Location-20-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location University of Kentucky/Markey Cancer Center ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-20 name: University of Kentucky/Markey Cancer Center Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 859-257-3379 * Principal investigator Rachel W. Miller address: Lexington Kentucky 40536 United States Positions - Longitude Latitude * -84.47772 37.98869 Generated Narrative: ResearchStudy #NCT05327010-Location-21-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location Ochsner Medical Center Jefferson ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-21 name: Ochsner Medical Center Jefferson Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 504-842-8084, Elisemarie.curry@ochsner.org * Principal investigator Daniel Johnson address: New Orleans Louisiana 70121 United States Positions - Longitude Latitude * -90.07507 29.95465 Generated Narrative: ResearchStudy #NCT05327010-Location-22-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location National Cancer Institute Developmental Therapeutics Clinic ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-22 name: National Cancer Institute Developmental Therapeutics Clinic Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 800-411-1222 * Principal investigator A P. Chen address: Bethesda Maryland 20892 United States Positions - Longitude Latitude * -77.10026 38.98067 Generated Narrative: ResearchStudy #NCT05327010-Location-23-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location National Institutes of Health Clinical Center ProgressStatuses - State * Active, not recruiting Generated Narrative: Location #NCT05327010-Location-23 name: National Institutes of Health Clinical Center address: Bethesda Maryland 20892 United States Positions - Longitude Latitude * -77.10026 38.98067 Generated Narrative: ResearchStudy #NCT05327010-Location-24-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location University of Kansas Cancer Center - North ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-24 name: University of Kansas Cancer Center - North Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 913-588-3671, KUCC_Navigation@kumc.edu * Principal investigator Joaquina C. Baranda address: Kansas City Missouri 64154 United States Positions - Longitude Latitude * -94.57857 39.09973 Generated Narrative: ResearchStudy #NCT05327010-Location-25-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location University of Kansas Cancer Center - Lee's Summit ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-25 name: University of Kansas Cancer Center - Lee's Summit Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 913-588-3671, KUCC_Navigation@kumc.edu * Principal investigator Joaquina C. Baranda address: Lee's Summit Missouri 64064 United States Positions - Longitude Latitude * -94.38217 38.91084 Generated Narrative: ResearchStudy #NCT05327010-Location-26-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location University of Kansas Cancer Center at North Kansas City Hospital ProgressStatuses - State * Temporarily Closed to Accrual Generated Narrative: Location #NCT05327010-Location-26 name: University of Kansas Cancer Center at North Kansas City Hospital address: North Kansas City Missouri 64116 United States Positions - Longitude Latitude * -94.56218 39.13 Generated Narrative: ResearchStudy #NCT05327010-Location-27-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location UNC Lineberger Comprehensive Cancer Center ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-27 name: UNC Lineberger Comprehensive Cancer Center Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 877-668-0683, cancerclinicaltrials@med.unc.edu * Principal investigator Shetal Patel address: Chapel Hill North Carolina 27599 United States Positions - Longitude Latitude * -79.05584 35.9132 Generated Narrative: ResearchStudy #NCT05327010-Location-28-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location University of Pittsburgh Cancer Institute (UPCI) ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-28 name: University of Pittsburgh Cancer Institute (UPCI) Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 412-647-8073 * Principal investigator Leonard J. Appleman address: Pittsburgh Pennsylvania 15232 United States Positions - Longitude Latitude * -79.99589 40.44062 Generated Narrative: ResearchStudy #NCT05327010-Location-29-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location University of Texas at Austin ProgressStatuses - State * Active, not recruiting Generated Narrative: Location #NCT05327010-Location-29 name: University of Texas at Austin address: Austin Texas 78712 United States Positions - Longitude Latitude * -97.74306 30.26715 Generated Narrative: ResearchStudy #NCT05327010-Location-30-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location University of Texas Medical Branch ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-30 name: University of Texas Medical Branch Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 409-772-1950, clinical.research@utmb.edu * Principal investigator Maurice Willis address: Galveston Texas 77555-0565 United States Positions - Longitude Latitude * -94.7977 29.30135 Generated Narrative: ResearchStudy #NCT05327010-Location-31-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location UT MD Anderson Cancer Center ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-31 name: UT MD Anderson Cancer Center Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 866-632-6789, askmdanderson@mdanderson.org * Principal investigator Timothy A. Yap address: Houston Texas 77030 United States Positions - Longitude Latitude * -95.36327 29.76328 Generated Narrative: ResearchStudy #NCT05327010-Location-32-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location University of Texas Health Science Center at San Antonio ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-32 name: University of Texas Health Science Center at San Antonio Contacts - Purpose Name Telecom * General contact John Sarantopoulos ph: 210-450-1785, sarantopoulo@uthscsa.edu * Principal investigator John Sarantopoulos address: San Antonio Texas 78229 United States Positions - Longitude Latitude * -98.49363 29.42412 Generated Narrative: ResearchStudy #NCT05327010-Location-33-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location Huntsman Cancer Institute/University of Utah ProgressStatuses - State * Active, not recruiting Generated Narrative: Location #NCT05327010-Location-33 name: Huntsman Cancer Institute/University of Utah address: Salt Lake City Utah 84112 United States Positions - Longitude Latitude * -111.89105 40.76078 Generated Narrative: ResearchStudy #NCT05327010-Location-34-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location University of Virginia Cancer Center ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-34 name: University of Virginia Cancer Center Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu * Principal investigator Linda R. Duska address: Charlottesville Virginia 22908 United States Positions - Longitude Latitude * -78.47668 38.02931 Generated Narrative: ResearchStudy #NCT05327010-Location-35-ResearchStudy Profile: ResearchStudySite partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial status: Active site: Location VCU Massey Comprehensive Cancer Center ProgressStatuses - State * Recruiting Generated Narrative: Location #NCT05327010-Location-35 name: VCU Massey Comprehensive Cancer Center Contacts - Purpose Name Telecom * General contact Site Public Contact ph: 804-628-6430, CTOclinops@vcu.edu * Principal investigator Emily N. Kinsey address: Richmond Virginia 23298 United States Positions - Longitude Latitude * -77.46026 37.55376
suggested alternative name: BETi ZEN-3694
suggested alternative name: Biological Sample Collection
suggested alternative name: Biospecimen Collected
suggested alternative name: Sample Collection
suggested alternative name: Specimen Collection
suggested alternative name: Diagnostic Imaging
suggested alternative name: Medical Imaging
Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter
NCT05327010 Comparison Group: Treatment (ZEN-3694, talazoparib)
Patients receive ZEN-3694 PO QD and talazoparib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo diagnostic imaging, blood sample collection, and tumor biopsy throughout the study.
Drug: BET Bromodomain Inhibitor ZEN-3694
City of Hope Comprehensive Cancer Center
USC / Norris Comprehensive Cancer Center
USC Norris Oncology/Hematology-Newport Beach
University of California Davis Comprehensive Cancer Center
UCHealth University of Colorado Hospital
Smilow Cancer Hospital Care Center-Trumbull
UF Health Cancer Institute - Gainesville
Emory University Hospital/Winship Cancer Institute
University of Kansas Clinical Research Center
University of Kansas Cancer Center-Overland Park
University of Kansas Hospital-Indian Creek Campus
University of Kansas Hospital-Westwood Cancer Center
University of Kentucky/Markey Cancer Center
National Cancer Institute Developmental Therapeutics Clinic
National Institutes of Health Clinical Center
University of Kansas Cancer Center - North
University of Kansas Cancer Center - Lee's Summit
University of Kansas Cancer Center at North Kansas City Hospital
UNC Lineberger Comprehensive Cancer Center
University of Pittsburgh Cancer Institute (UPCI)
University of Texas Health Science Center at San Antonio
Huntsman Cancer Institute/University of Utah
University of Texas MD Anderson Cancer Center LAO
Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
Phase 2 Trial of the Combination of the BET Inhibitor, ZEN003694 (ZEN-3694), and the PARP Inhibitor Talazoparib, in Patients With Molecularly-Selected Solid Tumors (ComBET)
Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial [Database Entry: FHIR ResearchStudy Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 583768. Revised 2026-07-27. Available at: https://fevir.net/resources/ResearchStudy/583768. Computable resource at: https://fevir.net/resources/ResearchStudy/583768#json.
This phase II trial tests whether ZEN003694 (ZEN-3694) in combination with talazoparib works to shrink tumors in patients with solid tumors that are unlikely to be cured or controlled with treatment and that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Another aim of this study is to find out if, and how, patients' genes influence their response to this specific drug combination. For this part of the study, investigators will run tests using samples of patients' tumor tissue and blood that will be collected during the study. ZEN-3694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that overproduce BET protein. Talazoparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Genes are pieces of the DNA code that individuals inherit from their parents. Some genes work to protect against cancer by correcting damage that can occur in the DNA when cells divide. BRCA1 and BRCA2 are two examples of these types of genes, and they are called tumor-suppressor genes. For example, if a person has a mutation in a BRCA1/2 gene they have a greatly increased risk of developing breast and ovarian cancer because their cells may no longer be able to completely repair damaged DNA. It is the accumulation of DNA damage which causes a cell to change into a cancerous cell. Other genes are also involved in this process, and these are called DNA damage repair genes. The KRAS mutation is a change in a protein in normal cells. Normally KRAS serves as an information hub for signals in the cell that lead to cell growth, but when there is a mutation in KRAS it signals too much and cells grow without being told to, which causes cancer. Combination therapy with ZEN-3694 and talazoparib may be effective at slowing or stopping tumor growth in patients with advanced cancer.
PRIMARY OBJECTIVE: I. To evaluate clinical response to the combination of BET bromodomain inhibitor ZEN-3694 (ZEN003694 \[ZEN-3694\]) and talazoparib using objective response rate (ORR) = (complete response \[CR\] + partial response \[PR\]). SECONDARY OBJECTIVES: I. To confirm the safety and toxicity profile of the combination of ZEN003694 (ZEN-3694) and talazoparib. II. To evaluate the clinical benefit rate (stable disease \[SD\] \> 6 months \[m\]+CR+PR) and progression-free survival (PFS). III. To assess the pharmacodynamics of the combination of ZEN003694 (ZEN-3694) and talazoparib using pre- and on-treatment tumor biopsies. IV. To characterize pharmacodynamic changes of exploratory biomarkers to the combination of ZEN003694 (ZEN-3694) and talazoparib in pre- and on-treatment tumor biopsies. V. To assess putative predictive biomarkers of response and resistance to the combination of ZEN003694 (ZEN-3694) and talazoparib. OUTLINE: Patients receive ZEN-3694 orally (PO) once daily (QD) and talazoparib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo diagnostic imaging, blood sample collection, and tumor biopsy throughout the study. After completion of study treatment, patients are followed up 30 days after administration of the last dose of study drug and then every 3 months for up to 2 years.
IPDSharingDescription: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Oversight Classifier: oversightHasDmc False
Oversight Classifier: isFdaRegulatedDrug True
Oversight Classifier: isFdaRegulatedDevice False
Systemically assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR = complete response + partial response. Complete response is defined as the disappearance of all target or non-target lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters of target or non-target lesions.
Assessed by radiographic disease assessments per RECIST v1.1. CBR = overall response + stable disease \> 6 months. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Assessed by radiographic disease assessments per RECIST v1.1.
Incidence and severity of adverse events and serious adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Includes significant changes in laboratory parameters, electrocardiograms, and vital signs. Summarized by grade and type.
Treatment-induced changes in phospho-protein signaling
Reverse phase proteomic array in pre- and on-treatment tumor biopsy samples conducted to assess treatment-induced changes in phospho-protein signaling, to correlate with treatment response and progression, and to assess changes in the levels of cytotoxic T lymphocyte precursor.
Correlation of single nucleotide variant (SNV) and copy number variant (CNV) profiles with treatment response
Whole exome sequencing conducted on pre-treatment biopsy and at progression to correlate SNV and CNV profiles with treatment response.
Ribonucleic acid (RNA) sequencing conducted for gene expression profiling.
Correlate mutation profiles with tumor sequencing
Using circulating tumor deoxyribonucleic acid (ctDNA) for correlation.
Correlate baseline mutations with treatment response
Correlate changes in ctDNA variant allele frequencies with response
Analysis of formalin-fixed paraffin-embedded and blood and blood samples
DNA, RNA, and protein analysis conducted.