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Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
NCT05327010 · View on ClinicalTrials.gov ↗
Study Summary
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
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy Procedure
- DRUG Talazoparib
- DRUG BET Bromodomain Inhibitor ZEN-3694
- PROCEDURE Diagnostic Imaging Testing
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center — Duarte
- City of Hope at Irvine Lennar — Irvine
- UC San Diego Moores Cancer Center — La Jolla
- Keck Medicine of USC Koreatown — Los Angeles
- Los Angeles General Medical Center — Los Angeles
- USC / Norris Comprehensive Cancer Center — Los Angeles
- USC Norris Oncology/Hematology-Newport Beach — Newport Beach
- University of California Davis Comprehensive Cancer Center — Sacramento
- UC San Diego Medical Center - Hillcrest — San Diego
Kansas
- University of Kansas Clinical Research Center — Fairway
- University of Kansas Cancer Center — Kansas City
- University of Kansas Cancer Center-Overland Park — Overland Park
- University of Kansas Hospital-Indian Creek Campus — Overland Park
- University of Kansas Hospital-Westwood Cancer Center — Westwood
Connecticut
- Yale University — New Haven
- Smilow Cancer Hospital Care Center-Trumbull — Trumbull
Colorado
- UCHealth University of Colorado Hospital — Aurora
Florida
- UF Health Cancer Institute - Gainesville — Gainesville
Georgia
- Emory University Hospital/Winship Cancer Institute — Atlanta
Illinois
- Northwestern University — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2022-11-14 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05327010
The ClinicalTrials.gov registry entry for NCT05327010 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05327010 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Kansas, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05327010 about?
NCT05327010 is a clinical study titled "Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial". 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 ...
What is the current status of trial NCT05327010?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2022-11-14. Estimated completion is 2026-12-31.
What conditions does trial NCT05327010 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05327010?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy Procedure (PROCEDURE), Talazoparib (DRUG), BET Bromodomain Inhibitor ZEN-3694 (DRUG), Diagnostic Imaging Testing (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05327010?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05327010 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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