http://hl7.org/fhir/uv/ebm/ResearchStudy/583768
type: ResearchStudy
node role: treeRoot
id:
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meta:
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  last updated:
    v: 2026-07-27T13:49:52.712Z
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text:
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    v: 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) cit…
contained: EvidenceVariable
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      v: suggested alternative name: ZEN-3694
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    text:
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      v: suggested alternative name: BMN673
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assigner:
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v: NCT05327010 Comparison Group: Treatment (ZEN-3694, talazoparib)

v: active

v: 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.

v: conceptual

text:
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ResearchStudy
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Location
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ResearchStudy
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Location
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ResearchStudy
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Location
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ResearchStudy
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Location
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address:
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position:
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ResearchStudy
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Location
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ResearchStudy
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Location
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ResearchStudy
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Location
id:
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name:
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position:
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ResearchStudy
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Location
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name:
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position:
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ResearchStudy
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Location
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position:
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ResearchStudy
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Location
id:
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name:
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address:
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  country:
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position:
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ResearchStudy
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site:
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  reference:
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  type:
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    l: Location
progress status:
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      system:
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        l: research-study-status
      code:
        v: active-but-not-recruiting
      display:
        v: Active, not recruiting

Location
id:
  v: NCT05327010-Location-10
name:
  v: Yale University
address:
  city:
    v: New Haven
  state:
    v: Connecticut
  postal code:
    v: 06520
  country:
    v: United States
position:
  longitude:
    v: -72.92816
  latitude:
    v: 41.30815

ResearchStudy
id:
  v: NCT05327010-Location-11-ResearchStudy
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        v: active-but-not-recruiting
      display:
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Location
id:
  v: NCT05327010-Location-11
name:
  v: Smilow Cancer Hospital Care Center-Trumbull
address:
  city:
    v: Trumbull
  state:
    v: Connecticut
  postal code:
    v: 06611
  country:
    v: United States
position:
  longitude:
    v: -73.20067
  latitude:
    v: 41.24287

ResearchStudy
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  v: NCT05327010-Location-12-ResearchStudy
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  type:
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      display:
        v: Active, not recruiting

Location
id:
  v: NCT05327010-Location-12
name:
  v: UF Health Cancer Institute - Gainesville
address:
  city:
    v: Gainesville
  state:
    v: Florida
  postal code:
    v: 32610
  country:
    v: United States
position:
  longitude:
    v: -82.32483
  latitude:
    v: 29.65163

ResearchStudy
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  v: NCT05327010-Location-13-ResearchStudy
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  type:
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    l: ResearchStudy
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site:
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  type:
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progress status:
  state:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-status
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      code:
        v: recruiting
      display:
        v: Recruiting

Location
id:
  v: NCT05327010-Location-13
name:
  v: Emory University Hospital/Winship Cancer Institute
contact:
  purpose:
    coding:
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  name:
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  telecom:
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    value:
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      code:
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      display:
        v: Principal investigator
  name:
    text:
      v: Ticiana A. Leal
address:
  city:
    v: Atlanta
  state:
    v: Georgia
  postal code:
    v: 30322
  country:
    v: United States
position:
  longitude:
    v: -84.38798
  latitude:
    v: 33.749

ResearchStudy
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  v: NCT05327010-Location-14-ResearchStudy
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    coding:
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      code:
        v: recruiting
      display:
        v: Recruiting

Location
id:
  v: NCT05327010-Location-14
name:
  v: Northwestern University
contact:
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    coding:
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        v: http://terminology.hl7.org/CodeSystem/research-study-party-role
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  name:
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      v: Site Public Contact
  telecom:
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    value:
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      code:
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      display:
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  name:
    text:
      v: Aparna Kalyan
address:
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    v: Chicago
  state:
    v: Illinois
  postal code:
    v: 60611
  country:
    v: United States
position:
  longitude:
    v: -87.65005
  latitude:
    v: 41.85003

ResearchStudy
id:
  v: NCT05327010-Location-15-ResearchStudy
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    l: ResearchStudy
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      display:
        v: Recruiting

Location
id:
  v: NCT05327010-Location-15
name:
  v: University of Kansas Clinical Research Center
contact:
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  name:
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contact:
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      code:
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      display:
        v: Principal investigator
  name:
    text:
      v: Joaquina C. Baranda
address:
  city:
    v: Fairway
  state:
    v: Kansas
  postal code:
    v: 66205
  country:
    v: United States
position:
  longitude:
    v: -94.6319
  latitude:
    v: 39.02223

ResearchStudy
id:
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progress status:
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      display:
        v: Recruiting

Location
id:
  v: NCT05327010-Location-16
name:
  v: University of Kansas Cancer Center
contact:
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  name:
    text:
      v: Joaquina C. Baranda
address:
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    v: Kansas City
  state:
    v: Kansas
  postal code:
    v: 66160
  country:
    v: United States
position:
  longitude:
    v: -94.62746
  latitude:
    v: 39.11417

ResearchStudy
id:
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      display:
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Location
id:
  v: NCT05327010-Location-17
name:
  v: University of Kansas Cancer Center-Overland Park
contact:
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    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-party-role
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  name:
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address:
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  state:
    v: Kansas
  postal code:
    v: 66210
  country:
    v: United States
position:
  longitude:
    v: -94.67079
  latitude:
    v: 38.98223

ResearchStudy
id:
  v: NCT05327010-Location-18-ResearchStudy
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progress status:
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    coding:
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        v: http://terminology.hl7.org/CodeSystem/research-study-status
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      code:
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      display:
        v: Recruiting

Location
id:
  v: NCT05327010-Location-18
name:
  v: University of Kansas Hospital-Indian Creek Campus
contact:
  purpose:
    coding:
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        v: http://terminology.hl7.org/CodeSystem/research-study-party-role
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contact:
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        v: Principal investigator
  name:
    text:
      v: Joaquina C. Baranda
address:
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    v: Overland Park
  state:
    v: Kansas
  postal code:
    v: 66211
  country:
    v: United States
position:
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    v: -94.67079
  latitude:
    v: 38.98223

ResearchStudy
id:
  v: NCT05327010-Location-19-ResearchStudy
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progress status:
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        v: http://terminology.hl7.org/CodeSystem/research-study-status
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      display:
        v: Recruiting

Location
id:
  v: NCT05327010-Location-19
name:
  v: University of Kansas Hospital-Westwood Cancer Center
contact:
  purpose:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-party-role
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contact:
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      code:
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      display:
        v: Principal investigator
  name:
    text:
      v: Joaquina C. Baranda
address:
  city:
    v: Westwood
  state:
    v: Kansas
  postal code:
    v: 66205
  country:
    v: United States
position:
  longitude:
    v: -94.6169
  latitude:
    v: 39.04056

ResearchStudy
id:
  v: NCT05327010-Location-20-ResearchStudy
meta:
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  type:
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    l: ResearchStudy
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progress status:
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    coding:
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        v: http://terminology.hl7.org/CodeSystem/research-study-status
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      code:
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      display:
        v: Recruiting

Location
id:
  v: NCT05327010-Location-20
name:
  v: University of Kentucky/Markey Cancer Center
contact:
  purpose:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-party-role
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      display:
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  name:
    text:
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  telecom:
    system:
      v: phone
    value:
      v: 859-257-3379
contact:
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    coding:
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        v: http://terminology.hl7.org/CodeSystem/research-study-party-role
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      code:
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      display:
        v: Principal investigator
  name:
    text:
      v: Rachel W. Miller
address:
  city:
    v: Lexington
  state:
    v: Kentucky
  postal code:
    v: 40536
  country:
    v: United States
position:
  longitude:
    v: -84.47772
  latitude:
    v: 37.98869

ResearchStudy
id:
  v: NCT05327010-Location-21-ResearchStudy
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    l: ResearchStudy
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progress status:
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    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-status
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      code:
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      display:
        v: Recruiting

Location
id:
  v: NCT05327010-Location-21
name:
  v: Ochsner Medical Center Jefferson
contact:
  purpose:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-party-role
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      display:
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  name:
    text:
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    system:
      v: phone
    value:
      v: 504-842-8084
  telecom:
    system:
      v: email
contact:
  purpose:
    coding:
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        v: http://terminology.hl7.org/CodeSystem/research-study-party-role
        l: research-study-party-role
      code:
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      display:
        v: Principal investigator
  name:
    text:
      v: Daniel Johnson
address:
  city:
    v: New Orleans
  state:
    v: Louisiana
  postal code:
    v: 70121
  country:
    v: United States
position:
  longitude:
    v: -90.07507
  latitude:
    v: 29.95465

ResearchStudy
id:
  v: NCT05327010-Location-22-ResearchStudy
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        v: http://terminology.hl7.org/CodeSystem/research-study-status
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      code:
        v: recruiting
      display:
        v: Recruiting

Location
id:
  v: NCT05327010-Location-22
name:
  v: National Cancer Institute Developmental Therapeutics Clinic
contact:
  purpose:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-party-role
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  name:
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  telecom:
    system:
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contact:
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      code:
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      display:
        v: Principal investigator
  name:
    text:
      v: A P. Chen
address:
  city:
    v: Bethesda
  state:
    v: Maryland
  postal code:
    v: 20892
  country:
    v: United States
position:
  longitude:
    v: -77.10026
  latitude:
    v: 38.98067

ResearchStudy
id:
  v: NCT05327010-Location-23-ResearchStudy
meta:
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    l: ResearchStudy
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progress status:
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    coding:
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        v: http://terminology.hl7.org/CodeSystem/research-study-status
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      code:
        v: active-but-not-recruiting
      display:
        v: Active, not recruiting

Location
id:
  v: NCT05327010-Location-23
name:
  v: National Institutes of Health Clinical Center
address:
  city:
    v: Bethesda
  state:
    v: Maryland
  postal code:
    v: 20892
  country:
    v: United States
position:
  longitude:
    v: -77.10026
  latitude:
    v: 38.98067

ResearchStudy
id:
  v: NCT05327010-Location-24-ResearchStudy
meta:
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    l: Location
progress status:
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    coding:
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        v: http://terminology.hl7.org/CodeSystem/research-study-status
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      code:
        v: recruiting
      display:
        v: Recruiting

Location
id:
  v: NCT05327010-Location-24
name:
  v: University of Kansas Cancer Center - North
contact:
  purpose:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-party-role
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  name:
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    value:
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  telecom:
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      v: email
contact:
  purpose:
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  country:
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position:
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  latitude:
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ResearchStudy
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Location
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name:
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position:
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ResearchStudy
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Location
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name:
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position:
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ResearchStudy
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Location
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ResearchStudy
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Location
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ResearchStudy
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Location
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ResearchStudy
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Location
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ResearchStudy
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Location
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name:
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position:
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ResearchStudy
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Location
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position:
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ResearchStudy
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Location
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position:
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ResearchStudy
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Location
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name:
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position:
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ResearchStudy
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Location
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name:
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  country:
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position:
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url:
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url:
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system:
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value:
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assigner:
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use:
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value:
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assigner:
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type:
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value:
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assigner:
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value:
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type:
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assigner:
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type:
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    v: Other Identifier
value:
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assigner:
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    v: CTEP

type:
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    v: U.S. NIH Grant/Contract
value:
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type:
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system:
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value:
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assigner:
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v: NCT05327010_FHIR_Transform

v: Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial

type:
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value:
  v: 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)

v: 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.

type:
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target: Uri
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type:
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target: Attachment
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    v: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter

type:
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target: Attachment
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  title:
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type:
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target: Attachment
  url:
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  title:
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v: active

coding:
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  code:
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  display:
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text:
  v: Design Masking: None (Open Label)

text:
  v: Design Allocation: NA

coding:
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coding:
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  code:
    v: SEVCO:01001
  display:
    v: interventional research

text:
  v: Advanced Malignant Solid Neoplasm

text:
  v: Metastatic Malignant Solid Neoplasm

text:
  v: Unresectable Malignant Solid Neoplasm

v: 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 therap…

v: 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.

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l: NCT05327010-Location-34-ResearchStudy
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l: NCT05327010-Location-35-ResearchStudy
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  v: IPDSharing: Yes

text:
  v: 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.

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  v: Minimum Age: 18 Years

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    v: 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.
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v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

type:
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    v: 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.
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    v: Using circulating tumor deoxyribonucleic acid (ctDNA) for correlation.
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  description:
    v: Using ctDNA for correlation.
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      value:
        v: NCT05327010-otherOutcome-4
    display:
      v: Correlate baseline mutations with treatment response
outcome measure:
  name:
    v: Correlate changes in ctDNA variant allele frequencies with response
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: exploratory
      display:
        v: Exploratory
  description:
    v: Using ctDNA for correlation.
  endpoint:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/583781
    reference:
      v: EvidenceVariable/583781
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT05327010-otherOutcome-5
    display:
      v: Correlate changes in ctDNA variant allele frequencies with response
outcome measure:
  name:
    v: Assess emergent resistant mutations
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: exploratory
      display:
        v: Exploratory
  description:
    v: Includes BRCA reversion.
  endpoint:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/583782
    reference:
      v: EvidenceVariable/583782
    type:
      v: EvidenceVariable
      l: EvidenceVariable

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

type:
  text:
    v: FEvIR Linking Identifier
system:
  v: https://fevir.net/FLI
  l: FLI
value:
  v: NCT05327010-otherOutcome-6
assigner:
  display:
    v: Computable Publishing LLC

v: Assess emergent resistant mutations

name:
  v: Analysis of formalin-fixed paraffin-embedded and blood and blood samples
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
      l: research-study-objective-type
    code:
      v: exploratory
    display:
      v: Exploratory
description:
  v: DNA, RNA, and protein analysis conducted.
endpoint:
  l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/583783
  reference:
    v: EvidenceVariable/583783
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  identifier:
    type:
      text:
        v: FEvIR Linking Identifier
    system:
      v: https://fevir.net/FLI
      l: FLI
    value:
      v: NCT05327010-otherOutcome-7
    assigner:
      display:
        v: Computable Publishing LLC
  display:
    v: Analysis of formalin-fixed paraffin-embedded and blood and blood samples