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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

Must not have

Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4

Patients who have received prior ATR, ATM, CHK, BET, EZH2, and/or PI3K inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I can swallow pills without needing to change their form.

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

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

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My chronic Hepatitis B virus is undetectable with treatment.

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

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I have had 1 to 3 previous chemotherapy treatments.

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I am 18 years old or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any strong medication that affects liver enzymes.

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I have previously been treated with specific inhibitors like ATR, ATM, or PI3K.

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My heart's QT interval is over 450msec, not due to electrolyte issues or family history.

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I am taking medication that affects blood clotting.

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I cannot stop taking medication that strongly affects my liver enzymes.

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I cannot stop taking certain medications for my condition.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

DLTs (Part II)

Dose-limiting toxicities (DLTs) (Part I)

Incidence of adverse events (Part I and II)

+1 more

Secondary study objectives

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

Measurements for c-myc (Part II)

Measurements for gammaH2AX (Part II)

+2 more

Other study objectives

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)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2790

Biopsy

2014

Completed Phase 4

~1150