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NCT05372640 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Metastatic Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 1
Development phase
45
Enrollment target
7
Study locations

NCT05372640: Recruiting Phase 1 study of Metastatic Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8, sponsored by National Cancer Institute (NCI).

NCT05372640 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 45 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (78% lower). The trial reports 7 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05372640, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 1
Development phase
45 participants
Enrollment target
7
Study locations

Study 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.

Primary Outcome

The toxicity of the combination will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v). 5.0 criteria.

Conditions Studied

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

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Biopsy Procedure
  • DRUG Abemaciclib
  • DRUG BET Bromodomain Inhibitor ZEN-3694
  • PROCEDURE Diagnostic Imaging Testing

Study Locations (7)

California

  • 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

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Pennsylvania

  • University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2023-08-10
Est. Completion 2026-06-01
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What NCT05372640 shows while recruiting

NCT05372640 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (78% lower).

The record links to 8 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT05372640 lists 7 locations in 4 states (California, Massachusetts, Pennsylvania).

Frequently Asked Questions

What is clinical trial NCT05372640 about?

NCT05372640 is a clinical study titled "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 cann...

What is the current status of trial NCT05372640?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2023-08-10. Estimated completion is 2026-06-01.

What conditions does trial NCT05372640 study?

This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Unresectable Malignant Solid Neoplasm.

What interventions are being tested in trial NCT05372640?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy Procedure (PROCEDURE), Abemaciclib (DRUG), BET Bromodomain Inhibitor ZEN-3694 (DRUG), Diagnostic Imaging Testing (PROCEDURE).

Who is sponsoring clinical trial NCT05372640?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05372640 being conducted?

This trial has 7 study locations across California, Massachusetts, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Malignant Solid Neoplasm

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05372640's enrollment target sits among peer trials

45 59th of 92 higher than 34 of 92 other Metastatic Malignant Solid Neoplasm trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05372640

Source: ClinicalTrials.gov NCT05372640, the US trial registry maintained by the National Library of Medicine. NCT05372640 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.