← Back to Search

Other

M1774 + ZEN-3694 for Ovarian and Endometrial Cancer

Phase 1

Recruiting

Led By Fiona Simpkins

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be able to swallow oral medications without altering the product formulation

Patients with microsatellite instability-high (MSI-H) and/or mismatch repair protein deficient (dMMR) endometrioid endometrial cancer must have previously received an immune checkpoint inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial tests if M1774+ZEN-3694 can safely stop tumor growth in ovarian/endometrial cancer patients. It has already been seen to be more effective than either drug alone.

Who is the study for?

This trial is for adults with recurrent ovarian or endometrial cancer who've had 1-3 prior treatments. They must be able to swallow pills, have stable brain metastases if present, and not be pregnant. Excluded are those on certain heart medications, with severe illnesses, gastrointestinal issues that affect drug absorption, or a history of allergic reactions to similar drugs.Check my eligibility

What is being tested?

The trial tests the safety and optimal dosages of M1774 combined with ZEN-3694 in patients whose ovarian or endometrial cancer has returned. These drugs may block enzymes needed for tumor cell growth and could work better together than alone.See study design

What are the potential side effects?

Potential side effects include typical reactions from cancer therapies such as fatigue, nausea, digestive disturbances but also specific concerns related to these drugs' action like possible liver enzyme changes and impact on blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can swallow pills without needing to change their form.

Select...

I have MSI-H or dMMR endometrial cancer and have been treated with an immune checkpoint inhibitor.

Select...

My cancer is a specific type of ovarian or endometrial carcinoma and has come back after treatment.

Select...

My chronic Hepatitis B virus is undetectable with treatment.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

I have had 1 to 3 previous chemotherapy treatments.

Select...

I am 18 years old or older.

Select...

I had Hepatitis C but have been successfully treated and cured.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

DLTs (Part II)

Dose-limiting toxicities (DLTs) (Part I)

Incidence of adverse events (Part I and II)

+1 more

Secondary outcome measures

Measurements for ARID1A protein and pathogenic alteration status (Part II)

Measurements for c-myc (Part II)

Measurements for gammaH2AX (Part II)

+2 more

Other outcome measures

Correlation of ARID1A gene alteration in circulating free tumor deoxyribonucleic acid (ctDNA) with tumor ARID1A genetic status and protein expression

Correlation of measurements for PK and pharmacodynamics (e.g., gH2AX and MYC) (Part II)

Correlation of objective response rate, CA-125 response, and overall survival (OS) with ARID1A pathogenic alteration status (Part II)

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (tuvusertib, BET bromodomain inhibitor ZEN-3694)Experimental Treatment8 Interventions

Patients receive tuvusertib and BET bromodomain inhibitor ZEN-3694 PO on study. Patients in the dose-escalation phase of the trial also undergo ECG during screening, collection of blood samples on study, and x-ray, CT, or MRI throughout the trial. Patients in the dose-expansion phase of the trial also undergo ECG during screening, biopsies during screening and on study, and x-ray, CT, or MRI, and collection of blood samples throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2720

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 2

~1700

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Electrocardiography

2014

N/A

~150

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,672 Previous Clinical Trials

40,926,630 Total Patients Enrolled

288 Trials studying Ovarian Cancer

73,832 Patients Enrolled for Ovarian Cancer

NRG OncologyOTHER

231 Previous Clinical Trials

100,792 Total Patients Enrolled

Fiona SimpkinsPrincipal InvestigatorNRG Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the population of participants in this research trial?

"Affirmative. Information hosted on clinicaltrials.gov indicates that this medical investigation, which was first shared on the 27th of May 2024, is currently recruiting participants. A total of 60 individuals are sought from a solitary medical centre."

Answered by AI

Is enrolment into this trial still available for interested participants?

"Affirmative. The clinical trial, which was initially posted on May 27th 2024 and revised most recently on September 15th 2023, is seeking additional participants for the study as indicated by data found on clinicaltrials.gov. 60 individuals are needed from 1 site to participate in this experiment."

Answered by AI

How does the safety profile of tuvusertib, ZEN-3694 and other related BET bromodomain inhibitors compare to current therapies?

"Our organisation's rankings place the security of this treatment combination (tuvusertib, BET bromodomain inhibitor ZEN-3694) at a 1 due to its Phase 1 status. This implies that there is minimal evidence indicating both safety and efficacy."

Answered by AI

What are the overarching objectives of this experiment?

"This clinical trial aims to evaluate DLTs in the first 28 days of treatment, as well as c-myc expression via Digital Spatial Profiling (DSP) using tumor samples. GammaH2AX and objective response rate will also be assessed by DSP and Response Evaluation Criteria in Solid Tumors (RECIST). Descriptive statistics such as mean, standard deviation, median are employed to summarise data; one-sided Wilcoxon signed rank tests are applied to compare pre-treatment vs on-treatment gammaH2AX expressions from patients treated at RP2D with evaluable bio specimens."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05950464.