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

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

Trial Details

NCT ID
NCT05372640
Phase
PHASE1
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Abemaciclib
  • BET Bromodomain Inhibitor ZEN-3694
  • Biopsy Procedure
  • Biospecimen Collection
  • Diagnostic Imaging Testing
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Newport Beach, California, United States|33.61891,-117.92895
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Participants must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measure…
  • 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 Clinica…

For full eligibility, visit ClinicalTrials.gov.

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