Trial · NCT05950464
Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer
NCT05950464, Phase 1, Recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer. Trials, record NCT05950464. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05950464
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer
- NCT number
- NCT05950464
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 65 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Recurrent Endometrial Carcinoma, Recurrent Endometrial Clear Cell Adenocarcinoma, Recurrent Endometrial Endometrioid Adenocarcinoma, Recurrent Endometrial Low Grade Endometrioid Adenocarcinoma, Recurrent Ovarian Clear Cell Adenocarcinoma, Recurrent Ovarian Endometrioid Adenocarcinoma, Recurrent Ovarian High Grade Serous Adenocarcinoma, Recurrent Ovarian Low Grade Endometrioid Adenocarcinoma, Recurrent Platinum-Resistant Ovarian Carcinoma
- Interventions
- BET Bromodomain Inhibitor ZEN-3694, Biopsy Procedure, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Tuvusertib, X-Ray Imaging
- First posted
- 2023-07-18
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-limiting toxicities (DLTs) (Part I) | Within the first cycle of study treatment (up to 28 days) | 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. |
| Primary | DLTs (Part II) | Within the first 2 cycles of study treatment (up to 56 days) | DLT is defined as any adverse events considered possibly, probably or definitely related to study drug combination as evaluated by NCI CTCAE v5.0. Within the ARID1A cohorts, the number of patients with DLTs will be summarized, and adverse events tabulated using the highest observed grade for each system organ class or preferred term, using CTCAE v5.0 criteria by cohort. |
| Primary | Measurements for gammaH2AX (PART II) | Baseline and cycle 1, day 8 (C1D8) | GammaH2AX will be assessed by immunohistochemistry (IHC) from tumor samples. Will be summarized using descriptive statistics (e.g., mean, standard deviation, median) by cohort and collection time point. One-sided Wilcoxon signed rank tests will be used for testing whether there is a change in gammaH2AX expression in the pre-treatment vs on-treatment tumor in the patients who have been treated at the recommended phase 2 dose (RP2D) and have evaluable bio-specimen by cohort, respectively. |
| Primary | Incidence of adverse events (Part I and II) | Up to 5 years | The frequency and severity of adverse events will be assessed by CTCAE v5. |
| Secondary | Measurements for c-myc (Part II) | Baseline and C1D8 | Will be assessed by Digital Spatial Profiling (DSP) using tumor samples. Will be summarized using descriptive statistics (e.g., mean, standard deviation, median) by cohort, biospecimen type, and collection time point. One-sided Wilcoxon signed rank tests will be applied to examine whether there is a change in c-myc expression in the pre-treatment vs on-treatment tumor in the patients who have been treated at the RP2D and have evaluable bio-specimen by cohort, respectively. |
| Secondary | Measurements for gammaH2AX (Part II) | Baseline and C1D8 | Will be assessed by DSP using tumor samples. Analyses will be performed in similar approach to the primary endpoint gammaH2AX expression by IHC. |
| Secondary | Measurements for ARID1A protein and pathogenic alteration status (Part II) | Baseline, C1D8, and at progression | Summary statistics (e.g., mean and standard deviation, median) for ARID1A protein by IHC and DSP in pre-treatment tumor will be provided for the 12-point score (measure of ARID1A positive staining cells by IHC) by cohort and mutation status (Khalique et al, 2018). ARID1A pathogenic alteration means there is loss of ARID1A protein as assessed by IHC and DSP. ARID1A wildtype means there is no mutation and ARID1A protein is present. The relationship between ARID1A protein and ARID1A pathogenic alteration status will be investigated by Wilcoxon rank-sum test. |
| Secondary | Objective response rate (Part II) | At 6 months | Objective response rate (ORR) is defined as the binomial proportion of evaluable patients with best overall response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of complete or partial response (CR or PR). |
| Secondary | Progression-free survival (Part II) | From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed at 6 months | Progression-free survival at six months (PFS) is defined as the binomial proportion of evaluable patients who survive without documentation of disease progression (RECIST 1.1) at least 6 months after starting study entry. |
| Other | Measurements of blood pharmacokinetics (PK) for ZEN003694 and ZEN003791 (Part I) | C1D1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, & 8 hours [hrs]); C1D8 (Pre-dose, 0.5, 1, 1.5, 2, 3, 4, & 8 hrs) | PK endpoints (area under the curve \[AUC\], maximum concentration \[Cmax\] and metabolic ratio of ZEN003694 and active metabolite ZEN003791, and M1774) will be summarized using descriptive statistics by dose level. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05950464
GET https://conductscience.org/api/trials/v1/NCT05950464/registered