Health Trials

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

ConditionsRecurrent Endometrial CarcinomaRecurrent Endometrial Clear Cell AdenocarcinomaRecurrent Endometrial Endometrioid AdenocarcinomaRecurrent Endometrial Low Grade Endometrioid AdenocarcinomaRecurrent Ovarian Clear Cell AdenocarcinomaRecurrent Ovarian Endometrioid AdenocarcinomaRecurrent Ovarian High Grade Serous AdenocarcinomaRecurrent Ovarian Low Grade Endometrioid AdenocarcinomaRecurrent Platinum-Resistant Ovarian Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

Qualifiers

PART I: Recurrent clear cell or endometrioid ovarian carcinoma (at least 50% morphology of clear cell and endometrioid required), recurrent clear cell and low grade endometrioid endometrial carcinoma (The International Federation of Gynecology and Obstetrics [FIGO] grade 1), or recurrent platinum resistant high grade serous ovarian carcinoma

NOTE: platinum-resistant disease is defined as progression within < 6 months from completion of platinum-based therapy. The date should be calculated from the last administered dose of platinum therapy

NOTE: Institutional pathology reports must be provided indicating at least 50% endometrioid or clear cell morphology for ovarian cancer.

NOTE: Patients with recurrent endometrial carcinoma must not be eligible for or decline treatment with curative intent.

Disqualifiers

Patients who are receiving any other investigational agents.

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

History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 or M1774 used in study.

Patients taking proton pump inhibitors given decreased solubility of M1774 with increased pH. Proton pump inhibitors must be discontinued 7 days prior to initiating the trial.

Trial design

Treatments tested in this trial

  • BET Bromodomain Inhibitor ZEN-3694
  • Biopsy Procedure
  • Biospecimen Collection
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Tuvusertib
  • X-Ray Imaging

Treatment groups

65 Participants
are divided into 1 treatment group

Sponsors and collaborators

National Cancer Institute (NCI)

Lead sponsor

NRG Oncology

Collaborator

Source ClinicalTrials.gov