NCT05372640 Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors
| NCT ID | NCT05372640 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Anatomic Stage III Breast Cancer AJCC v8 |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2023-08-10 |
| Primary Completion | 2026-06-01 |
Trial Parameters
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Brief Summary
This phase I trial tests the safety, side effects, and best dose of ZEN003694 when given together with abemaciclib in treating patients with NUT carcinoma, breast cancer or other solid tumors that have spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). ZEN003694 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. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ZEN003694 and abemaciclib may help shrink or stabilize cancer in patients with NUT carcinoma, breast cancer or other solid tumors.
Eligibility Criteria
Inclusion Criteria: * Participants must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective * Dose Escalation Cohort Only: Participants must have evaluable disease or measurable disease per RECIST 1.1 criteria * Dose Expansion Cohort Only: * Participants must have a diagnosis of NUT carcinoma (NC) based on standard criteria for the disease, with diagnostic testing performed in a Clinical Laboratory Improvement Act (CLIA) certified laboratory: * Ectopic expression of NUT protein per World Health Organization (WHO) criteria as determined by immunohistochemistry (IHC) testing, OR * Detection of the NUT gene translocation as determined by fluorescence in situ hybridization (FISH) testing, OR * Detection of the NUT gene translocation as determined by either deoxyribonucleic acid (DNA) next-generation sequencing (NGS) or ribonucleic acid (RNA) sequencing. * Participants must
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