OncRef

Clinical Trial: 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

Status:

RECRUITING

Phase:

Phase 1

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-07-31

Study Overview

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.

Official Title

A Phase 1 Study of BET Bromodomain Inhibitor ZEN003694 in Combination With the CDK4/6 Inhibitor Abemaciclib in Patients With NUT Carcinoma, Breast Cancer and Other Solid Tumors

Conditions

Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic NUT Carcinoma, Unresectable Breast Carcinoma, Unresectable Malignant Solid Neoplasm, Unresectable NUT Carcinoma

Intervention / Treatment

  • Drug: Abemaciclib
  • Drug: BET Bromodomain Inhibitor ZEN-3694
  • Procedure: Biopsy Procedure
  • Procedure: Biospecimen Collection
  • Procedure: Diagnostic Imaging Testing

Other Study ID Numbers

  • NCI-2022-04100
  • NCI-2022-04100
  • 10509
  • 10509
  • UM1CA186709

Start Date (Actual)

2023-08-10

Primary Completion Date (Estimated)

2027-06-07

Study Completion Date (Estimated)

2027-06-07

Enrollment (Estimated)

45

Study Type

Interventional

Phase

Phase 1