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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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 153 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing Completion moved earlier from Dec 31, 2027 to Dec 31, 2026 · Study sites: 36 to 35 · Eligibility criteria shortened, about 11 words · 1 more Show 4 more changesShow less
    • Completion moved earlier from Dec 31, 2027 to Dec 31, 2026
    • Study sites: 36 to 35
    • Eligibility criteria shortened, about 11 words
    • Study description revised
  2. Site details revised at 2 of 36 sitesv152
  3. Re-verified, no change to tracked fieldsv151
  4. Study sites revised (36)v150 See this version in full on ClinicalTrials.gov ↗
  5. Site contacts updated at 1 of 36 sitesv149
Show 13 earlier versionsHide 13 earlier versions
  1. Site contacts updated at 1 of 36 sitesv148
  2. Site details revised at 1 of 36 sitesv147
  3. Re-verified, no change to tracked fieldsv146
  4. Study sites revised (36)v145 See this version in full on ClinicalTrials.gov ↗
  5. Re-verified, no change to tracked fieldsv144
  6. Site details revised at 1 of 36 sitesv143
  7. 7 versions Re-verified since Apr 1, 2026, no change to tracked fieldsv136-v142
  1. Completion pushed from Dec 31, 2026 to Dec 31, 2027 Site details revised at 1 of 36 sitesv135 Show 1 more changeShow less
    • Site details revised at 1 of 36 sites
  2. Site details revised at 1 of 36 sitesv134
  3. 30 versions Re-verified since Feb 11, 2026, no change to tracked fieldsv104-v133
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05327010
Lead Sponsor National Cancer Institute (NCI)
Conditions Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov