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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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2023-08-10 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05372640
The ClinicalTrials.gov registry entry for NCT05372640 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (78% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
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 reports 7 study locations spanning 4 distinct geographic areas - top geographies include 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.
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