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NCT05950464 · ClinicalTrials.gov registry record · Phase 1

Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer

A Phase 1 study of Recurrent Endometrial Carcinoma and Recurrent Platinum-Resistant Ovarian Carcinoma, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 1
Development phase
60
Enrollment target
14
Study locations

NCT05950464: Recruiting Phase 1 study of Recurrent Endometrial Carcinoma and Recurrent Platinum-Resistant Ovarian Carcinoma, sponsored by National Cancer Institute (NCI).

NCT05950464 is a Phase 1 study of Recurrent Endometrial Carcinoma and Recurrent Platinum-Resistant Ovarian Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants, below the 249-participant average among 19 other Recurrent Endometrial Carcinoma trials with a reported enrollment target (76% lower). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05950464, a Phase 1 study of Recurrent Endometrial Carcinoma and Recurrent Platinum-Resistant Ovarian Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 1
Development phase
60 participants
Enrollment target
14
Study locations

Study Summary

This phase Ib trial tests the safety, side effects, and best dose of M1774 when given with ZEN-3694 in treating patients with ovarian and endometrial cancer that has come back (recurrent). M1774 and ZEN-3694 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. M1774 and ZEN-3694 combined together has demonstrated to be better than either drug alone in killing ovarian tumor cells.

Primary Outcome

DLT is defined as any adverse events considered possibly, probably or definitely related to study drug combination as evaluated by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. A Bayesian Optimal Interval (BOIN) design will be used to determine the MTD (Yuan et al. 2016). Will be summarized by dose level.

Conditions Studied

Recurrent Endometrial Carcinoma Recurrent Platinum-Resistant Ovarian Carcinoma Recurrent Endometrial Endometrioid Adenocarcinoma Recurrent Ovarian Clear Cell Adenocarcinoma Recurrent Ovarian Endometrioid Adenocarcinoma Recurrent Endometrial Clear Cell Adenocarcinoma Recurrent Ovarian High Grade Serous Adenocarcinoma Recurrent Endometrial Low Grade Endometrioid Adenocarcinoma Recurrent Ovarian Low Grade Endometrioid Adenocarcinoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy Procedure
  • DRUG BET Bromodomain Inhibitor ZEN-3694
  • PROCEDURE Electrocardiography

Study Locations (14)

Ohio

  • Case Western Reserve University - Cleveland
  • Cleveland Clinic Foundation - Cleveland
  • Ohio State University Comprehensive Cancer Center - Columbus

Pennsylvania

  • NRG Oncology - Philadelphia
  • University of Pennsylvania/Abramson Cancer Center - Philadelphia
  • Thomas Jefferson University Hospital - Philadelphia

Georgia

  • Augusta University Medical Center - Augusta

Illinois

  • University of Chicago Comprehensive Cancer Center - Chicago

Iowa

  • University of Iowa/Holden Comprehensive Cancer Center - Iowa City

Michigan

  • Wayne State University/Karmanos Cancer Institute - Detroit

New Mexico

  • University of New Mexico Cancer Center - Albuquerque

Oklahoma

  • University of Oklahoma Health Sciences Center - Oklahoma City

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2023-12-18
Est. Completion 2026-04-30
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What NCT05950464 shows while recruiting

NCT05950464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 249-participant average among 19 other Recurrent Endometrial Carcinoma trials with a reported enrollment target (76% lower).

The record links to 9 conditions, with Recurrent Endometrial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT05950464 lists 14 locations in 10 states (Ohio, Pennsylvania, Georgia).

Frequently Asked Questions

What is clinical trial NCT05950464 about?

NCT05950464 is a clinical study titled "Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer". This phase Ib trial tests the safety, side effects, and best dose of M1774 when given with ZEN-3694 in treating patients with ovarian and endometrial cancer that has come back (recurrent). M1774 and ZEN-3694 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. M...

What is the current status of trial NCT05950464?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2023-12-18. Estimated completion is 2026-04-30.

What conditions does trial NCT05950464 study?

This clinical trial studies the following conditions: Recurrent Endometrial Carcinoma, Recurrent Platinum-Resistant Ovarian Carcinoma, Recurrent Endometrial Endometrioid Adenocarcinoma, Recurrent Ovarian Clear Cell Adenocarcinoma, Recurrent Ovarian Endometrioid Adenocarcinoma.

What interventions are being tested in trial NCT05950464?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), BET Bromodomain Inhibitor ZEN-3694 (DRUG), Electrocardiography (PROCEDURE).

Who is sponsoring clinical trial NCT05950464?

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

Where is trial NCT05950464 being conducted?

This trial has 14 study locations across Georgia, Illinois, Iowa, Michigan, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Recurrent Endometrial Carcinoma

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 NCT05950464's enrollment target sits among peer trials

60 8th of 19 higher than 12 of 19 other Recurrent Endometrial Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent Endometrial Carcinoma 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 NCT05950464

Source: ClinicalTrials.gov NCT05950464, the US trial registry maintained by the National Library of Medicine. NCT05950464 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.