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

Part of paid clinical trials in Augusta, Georgia.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05950464
Phase
PHASE1
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BET Bromodomain Inhibitor ZEN-3694 — DRUG
    Given PO
  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Tuvusertib — DRUG
    Given PO
  • X-Ray Imaging — PROCEDURE
    Undergo x-ray

Study Details

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.

Key Dates

Start date
Dec 18, 2023
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (tuvusertib, BET bromodomain inhibitor ZEN-3694)
    Patients receive tuvusertib PO QD either on days 2-14 of cycle 1 and days 1-14 of subsequent cycles or days 1-14 of each cycle and BET bromodomain inhibitor ZEN-3694 PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in the dose-escalation phase of the trial also undergo 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 biopsies during screening and on study, and x-ray, CT, or MRI, and collection of blood samples throughout the trial.

Primary Outcome Measure

Dose-limiting toxicities (DLTs) (Part I) [ Time Frame: Within the first cycle of study treatment (up to 28 days) ]

Locations (14)

FacilityCityStateZIPSite coordinators
Augusta University Medical CenterAugustaGeorgia30912
Site Public Contact
[email protected]
706-721-2388
Sharad A. Ghamande (PRINCIPAL_INVESTIGATOR)
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637
Site Public Contact
[email protected]
773-702-8222
Katherine C. Kurnit (PRINCIPAL_INVESTIGATOR)
University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowa52242
Site Public Contact
800-237-1225
David P. Bender (PRINCIPAL_INVESTIGATOR)
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201
Site Public Contact
[email protected]
800-527-6266
Ira S. Winer (PRINCIPAL_INVESTIGATOR)
University of New Mexico Cancer CenterAlbuquerqueNew Mexico87106
Site Public Contact
[email protected]
505-925-0348
Carolyn Y. Muller (PRINCIPAL_INVESTIGATOR)
Case Western Reserve UniversityClevelandOhio44106-
Cleveland Clinic FoundationClevelandOhio44195
Site Public Contact
[email protected]
866-223-8100
Peter G. Rose (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Site Public Contact
[email protected]
800-293-5066
John L. Hays (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Site Public Contact
[email protected]
405-271-8777
Lauren E. Dockery (PRINCIPAL_INVESTIGATOR)
NRG OncologyPhiladelphiaPennsylvania19103
Fiona Simpkins
[email protected]
Fiona Simpkins (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Site Public Contact
[email protected]
215-600-9151
Mitchell I. Edelson (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania/Abramson Cancer CenterPhiladelphiaPennsylvania19104
Site Public Contact
[email protected]
215-349-8245
Fiona Simpkins (PRINCIPAL_INVESTIGATOR)
Women and Infants HospitalProvidenceRhode Island02905
Site Public Contact
401-274-1122
Cara A. Mathews (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Site Public Contact
414-805-3666
William H. Bradley (PRINCIPAL_INVESTIGATOR)

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Augusta University Medical Center· Augusta, GAUniversity of Chicago Comprehensive Cancer Center· Chicago, ILUniversity of Iowa/Holden Comprehensive Cancer Center· Iowa City, IAWayne State University/Karmanos Cancer Institute· Detroit, MIUniversity of New Mexico Cancer Center· Albuquerque, NMCase Western Reserve University· Cleveland, OH

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