RecruitingPhase 1NCT05691504

Testing the Combination of APG-1252 (Pelcitoclax) and Cobimetinib in Recurrent Ovarian and Endometrial Cancers

A Phase 1 Study of APG-1252 (Pelcitoclax) and Cobimetinib in Recurrent Ovarian and Endometrial Cancers


Sponsor

National Cancer Institute (NCI)

Enrollment

42 participants

Start Date

Sep 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial tests the safety, side effects, and best dose of combination therapy with pelcitoclax (APG-1252) and cobimetinib in treating patients with ovarian and endometrial cancers that have come back after a period of improvement (recurrent). APG-1252 is a drug that inhibits activity of proteins that prevent cell death, leading to increased cell death and reduced cell growth. Cobimetinib is used in patients whose cancer has a mutated (changed) form of a gene called BRAF. It is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving APG-1252 in combination with cobimetinib may shrink or stabilize tumor in patients with recurrent ovarian and endometrial cancers.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the combination of two targeted drugs — APG-1252 (pelcitoclax) and cobimetinib — in women with recurrent ovarian cancer or endometrial cancer that has come back after prior treatment. **You may be eligible if...** - You are 18 or older - You have recurrent ovarian, fallopian tube, peritoneal, or endometrial cancer that has spread or cannot be surgically removed - You have had at least one prior platinum-based chemotherapy treatment - For ovarian cancer: your cancer progressed within 6 months of your last platinum treatment (platinum-resistant) - If you have low-grade serous ovarian cancer: you must have received a prior MEK inhibitor - If you have MSI-high or dMMR endometrial cancer: you must have received or be ineligible for immunotherapy **You may NOT be eligible if...** - You have never received platinum-based chemotherapy - You are pregnant or unwilling to use contraception - Your organ function is significantly impaired - You have serious cardiovascular or other conditions that would make treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood

DRUGCobimetinib

Given PO

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREEchocardiography Test

Undergo ECHO

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

DRUGPelcitoclax

Given IV


Locations(6)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

National Cancer Institute Developmental Therapeutics Clinic

Bethesda, Maryland, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

View Full Details on ClinicalTrials.gov

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NCT05691504


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