BMS-986504 + Olaparib for Cancer

Overseen By Jordi Rodon Ahnert, MD, PHD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: CYP3A inhibitors/inducers, BCRP substrates, P-gp substrates

Disqualifiers: Additional malignancy, Brain metastases, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical research study is to learn about the safety and effects of BMS-986504 in combination with olaparib in patients with advanced solid tumors with MTAP loss.

Who Is on the Research Team?

Jordi Rodon Ahnert, MD, PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have lost MTAP. Participants must be able to swallow pills, have acceptable blood test results, and no other effective treatment options available. Pregnant or breastfeeding individuals can't join.

Inclusion Criteria

My cancer can be measured and biopsied according to specific criteria.

I am 18 years old or older.

I am a woman who can have children, tested negative for pregnancy, and agree to use birth control.

Exclusion Criteria

I am currently on IV antibiotics for an infection.

I have a stomach or intestine problem that affects how I absorb medication.

I have not received a live vaccine in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986504 in combination with olaparib. Part A involves dose escalation, and Part B involves pharmacodynamic expansion cohorts.

12 months

Outpatient basis

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Olaparib

Trial Overview

The study tests the safety and effects of a new drug combo: BMS-986504 with Olaparib, in patients whose tumors lack MTAP. It's an early-phase trial to determine how well these drugs work together against cancer.

How Is the Trial Designed?

Group I: Part B Pharmacodynamic Expansion Cohort 2: Treatment with Olaparib at C1D1 + BMS-986504 at C1D15 Experimental Treatment 2 Interventions

Study treatment will be administered on an outpatient basis

Group II: Part B Pharmacodynamic Expansion Cohort 1: Treatment with BMS-986504 at C1D1 + Olaparib at C1D15 Experimental Treatment 2 Interventions

Study treatment will be administered on an outpatient basis

Group III: Part A Dose Escalation: Treatment with BMS-986504 + Olaparib Experimental Treatment 2 Interventions

Study treatment will be administered on an outpatient basis

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+