At a glance
ClinicalIndex Comparison Record- ✓Recurrent clear cell or endometrioid ovarian carcinoma with ≥50% morphology, or recurrent clear cell/FIGO grade 1 endometrioid endometrial carcinoma, or recurrent platinum-resistant high-grade serous ovarian carcinoma
- ✓Platinum-resistant disease defined as progression within <6 months from completion of platinum-based therapy
- ✓Age ≥18 years
- ✓ECOG performance status ≤2
- ✕Currently receiving other investigational agents
- ✕Prior ATR, ATM, CHK, BET, EZH2, and/or PI3K inhibitors
- ✕Allergic reactions to compounds similar in composition to ZEN003694 or M1774
- ✕Currently taking proton pump inhibitors (must discontinue 7 days prior)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1B Study of Combination ATR (M1774) and BET Inhibition (ZEN003694) to Exploit ARID1A Loss in Recurrent Ovarian and Endometrial Cancer
In Brief
A Phase 1 clinical trial evaluating BET Bromodomain Inhibitor ZEN-3694, Biopsy Procedure, and 5 other interventions for Recurrent Endometrial Carcinoma and 8 related conditions. Currently recruiting, targeting 65 participants across 14 sites.
Signals
Detailed Summary
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.
Study Details
Timeline
Arms & Interventions
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.
Interventions
Given PO
Undergo biopsy
Undergo collection of blood samples
Undergo CT
Undergo MRI
Given PO
Undergo x-ray