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Protein Inhibitor

Pelcitoclax + Cobimetinib for Recurrent Ovarian and Endometrial Cancers

Phase 1

Recruiting

Led By Joyce F Liu

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically or cytologically confirmed recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, or metastatic or unresectable endometrial cancer with no standard curative or palliative measures available

Patients with low grade serous ovarian cancer must have received a prior MEK inhibitor at a demonstrated therapeutic dose

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial tests a new drug combo to treat ovarian & endometrial cancers that have returned. It blocks abnormal proteins that signal cancer cells to multiply and may help slow or stop the spread of cancer.

Who is the study for?

This trial is for adults with recurrent ovarian or endometrial cancer who've had platinum-based therapy and, if applicable, specific prior treatments based on their cancer type. They must be able to take oral meds, provide tissue samples if available, use contraception if needed, and have no other health issues that could interfere.Check my eligibility

What is being tested?

The trial tests a combo of two drugs: Pelcitoclax (APG-1252) which may help kill cancer cells by blocking certain proteins, and Cobimetinib which targets abnormal proteins in cancers with a BRAF gene mutation. The goal is to see if this drug duo can shrink or stabilize the tumors.See study design

What are the potential side effects?

Potential side effects include reactions related to cell death such as fatigue and nausea; kinase inhibitors like Cobimetinib might cause skin rash, vision changes or liver problems. Each patient's reaction will vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has returned or spread and cannot be surgically removed, with no standard treatments left.

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I have low grade serous ovarian cancer and have been treated with a MEK inhibitor.

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I have had platinum-based chemotherapy before, not just with radiation.

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My cancer can be measured and biopsied.

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I am mostly self-sufficient and can carry out daily activities.

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I am 18 years old or older.

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I can swallow pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of dose-limiting toxicities (DLTs)

Maximum tolerable dose

Recommended phase 2 dose

Secondary outcome measures

Clinical benefit rate

Duration of response (DoR)

Incidence of adverse events

+3 more

Other outcome measures

Effect of combination APG-1252 and cobimetinib on RAS pathway signaling

Markers of response and resistance to APG-1252 and cobimetinib

Markers of response and resistance to APG-1252 and cobimetinib via sequencing

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pelcitoclax, cobimetinib)Experimental Treatment8 Interventions

Patients receive APG-1252 IV Q7D. Patients also receive cobimetinib PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy and collection of blood on study and undergo CT and/or MRI throughout the trial. Patients undergo ECHO or MUGA during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 2

~1700

Cobimetinib

2017

Completed Phase 3

~2660

Computed Tomography

2017

Completed Phase 2

~2720

Echocardiography

2013

Completed Phase 4

~11670

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,672 Previous Clinical Trials

40,926,399 Total Patients Enrolled

75 Trials studying Endometrial Cancer

73,374 Patients Enrolled for Endometrial Cancer

Joyce F LiuPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO

3 Previous Clinical Trials

804 Total Patients Enrolled

Media Library

APG-1252 (Protein Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05691504 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the combination of pelcitoclax and cobimetinib received clearance from the FDA?

"As this is an early-stage trial, with limited information on safety and efficacy, the risk of Treatment (pelicitoclax, cobimetinib) was rated 1 out of 3."

Answered by AI

What is the primary goal of this research endeavor?

"This clinical trial, which will last for up to 28 days, aims to quantify the occurrence of dose-limiting toxicities (DLTs). Secondary objectives include measuring adverse events through National Cancer Institute CTCAE version 5.0, assessing response rate (CR + PR), and establishing progression-free survival with Kaplan-Meier curves by dose level where feasible."

Answered by AI

What is the current participant count for this research endeavor?

"Indeed, the clinical trial in question is currently looking for participants. This investigation was posted on May 12th 2023 and updated on 27th of the same month. The research study requires 42 individuals across 1 medical facility to take part."

Answered by AI

Are new participants able to enroll in this clinical research?

"Affirmative. Clinicaltrials.gov records show that this clinical trial, posted on the 12th of May 2023 and recently updated on the 27th of May 2023, is still actively seeking participants. 42 patients will be admitted at a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Testing the Combination of APG-1252 (Pelcitoclax) and Cobimetinib in Recurrent Ovarian and Endometrial Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05691504.

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