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OncoMatch/Clinical Trials/NCT05691504

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

Is NCT05691504 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Cobimetinib and Pelcitoclax for advanced endometrial carcinoma.

Phase 1RecruitingNational Cancer Institute (NCI)NCT05691504Data as of May 2026

Treatment: Cobimetinib · PelcitoclaxThis 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.

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Extracted eligibility criteria

Cancer type

Endometrial Cancer

Ovarian Cancer

Biomarker criteria

Allowed: MSH2 mismatch repair deficient

Patients with microsatellite instability (MSI) or mismatch repair deficient (dMMR) endometrial cancer must have received prior PD-1 or PD-L1 directed immunooncology (IO) therapy or be considered medically ineligible to receive such therapy

Allowed: MSH6 mismatch repair deficient

Patients with microsatellite instability (MSI) or mismatch repair deficient (dMMR) endometrial cancer must have received prior PD-1 or PD-L1 directed immunooncology (IO) therapy or be considered medically ineligible to receive such therapy

Allowed: MLH1 mismatch repair deficient

Patients with microsatellite instability (MSI) or mismatch repair deficient (dMMR) endometrial cancer must have received prior PD-1 or PD-L1 directed immunooncology (IO) therapy or be considered medically ineligible to receive such therapy

Allowed: PMS2 mismatch repair deficient

Patients with microsatellite instability (MSI) or mismatch repair deficient (dMMR) endometrial cancer must have received prior PD-1 or PD-L1 directed immunooncology (IO) therapy or be considered medically ineligible to receive such therapy

Disease stage

Required: Stage III, IV (AJCC v8)

Metastatic disease required

metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: platinum-based chemotherapy

Patients must have received at least one prior line of platinum-based systemic therapy. Platinum received together with radiation as a sensitizing agent is not considered a systemic line of therapy

Must have received: MEK inhibitor (trametinib, binimetinib, cobimetinib) — low grade serous ovarian cancer

Patients with low grade serous ovarian cancer must have received a prior MEK inhibitor at a demonstrated therapeutic dose (i.e., trametinib 1mg daily or higher; binimetinib 30mg twice daily or higher). Patients who have had prior cobimetinib must have been able to tolerate cobimetinib at the dose and schedule they would receive it on study

Must have received: anti-PD-1 therapy — MSI or dMMR endometrial cancer

Patients with microsatellite instability (MSI) or mismatch repair deficient (dMMR) endometrial cancer must have received prior PD-1 or PD-L1 directed immunooncology (IO) therapy or be considered medically ineligible to receive such therapy

Cannot have received: BCL family inhibitor

Patients with prior exposure to BCL family inhibitors

Lab requirements

Blood counts

Absolute neutrophil count >= 1,500/mcL; Platelets >= 100,000/mcL; Hemoglobin > 9 g/dL

Kidney function

Creatinine <= 1.5 x institutional ULN OR GFR >= 50 ml/min (CKD-EPI)

Liver function

Total bilirubin <= 1.5 x institutional ULN; AST/ALT < 3 x institutional ULN

Cardiac function

LVEF >= institutional lower limit of normal (LLN) or above 50%, whichever is higher, by ECHO or MUGA

Absolute neutrophil count >= 1,500/mcL; Platelets >= 100,000/mcL; Hemoglobin > 9 g/dL; Total bilirubin <= 1.5 x institutional ULN; AST/ALT < 3 x institutional ULN; Creatinine <= 1.5 x institutional ULN OR GFR >= 50 ml/min (CKD-EPI); LVEF >= institutional lower limit of normal (LLN) (or above 50%, whichever is higher) by echocardiogram (ECHO) or multigated acquisition scan (MUGA)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Emory University Hospital/Winship Cancer Institute · Atlanta, Georgia
  • Johns Hopkins University/Sidney Kimmel Cancer Center · Baltimore, Maryland
  • National Cancer Institute Developmental Therapeutics Clinic · Bethesda, Maryland
  • National Institutes of Health Clinical Center · Bethesda, Maryland
  • Dana-Farber Cancer Institute · Boston, Massachusetts

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