BMS-986504 + Olaparib for Cancer

JR
Overseen ByJordi Rodon Ahnert, MD, PHD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effects of a new treatment combining BMS-986504 (an experimental treatment) and olaparib for individuals with advanced solid tumors lacking a specific protein called MTAP. The study includes different parts to test the treatments in unique ways, with some groups starting both drugs together and others taking them at different times. It suits those with advanced or metastatic cancers, such as pancreatic or bile duct cancer, who have no other treatment options. Participants should have tumors that lack the MTAP protein. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) from prior therapies, including 3 weeks from any treatment for systemic tumor control and 5 half-lives from small molecule targeted agents. Additionally, you cannot use strong CYP3A inhibitors or inducers within 14 days before starting the study and during the study period.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of BMS-986504 and olaparib is being tested for safety in people with advanced solid tumors. Previous studies have examined how well patients tolerate this treatment pair. Some side effects have been reported and graded to help doctors assess their severity.

Olaparib, one of the drugs in this combination, already has FDA approval for other uses, providing some reassurance about its safety. However, BMS-986504 remains in the early testing phase (Phase 1), so information on its safety in humans is limited. This phase is crucial for assessing safety and identifying any side effects. Joining this trial helps researchers gather more information about the safety of this new treatment combination.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of BMS-986504 and Olaparib for cancer treatment because of its unique dual-action approach. Traditional cancer treatments often focus on single pathways, but BMS-986504 targets specific cancer cell mechanisms, potentially enhancing the effectiveness of Olaparib, a PARP inhibitor that already disrupts cancer cell DNA repair. This combination could lead to more effective tumor suppression and improved outcomes for patients, offering a new hope beyond current standard options like chemotherapy and radiation.

What evidence suggests that this trial's treatments could be effective for advanced solid tumors with MTAP loss?

Research has shown that olaparib can effectively treat certain cancers, such as pancreatic cancer, especially when specific genetic changes (BRCA1/2) are present. In the POLO study, it helped patients live longer without disease progression. Additionally, when combined with chemotherapy, olaparib can enhance treatment effectiveness and extend survival in people with advanced triple-negative breast cancer. This trial examines BMS-986504 in combination with olaparib to assess its efficacy, particularly in advanced solid tumors with a genetic feature called MTAP loss. Although limited data exists on this combination, ongoing research is evaluating its safety and potential benefits.12467

Who Is on the Research Team?

JR

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.
See 11 more

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.
See 10 more

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?

3

Treatment groups

Experimental Treatment

Group I: Part B Pharmacodynamic Expansion Cohort 2: Treatment with Olaparib at C1D1 + BMS-986504 at C1D15Experimental Treatment2 Interventions
Group II: Part B Pharmacodynamic Expansion Cohort 1: Treatment with BMS-986504 at C1D1 + Olaparib at C1D15Experimental Treatment2 Interventions
Group III: Part A Dose Escalation: Treatment with BMS-986504 + OlaparibExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

Phase 1b Trial of BMS-986504 in Combination With ...

Primary Objective: 1. To determine the safety and tolerability of BMS-986504 in combination with olaparib in patients with advanced solid tumors with MTAP ...

Phase 1b Trial of BMS-986504 in Combination With ...

Outcome Measure, Measure Description, Time Frame ; Safety and Adverse Events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute ...

Medical management of pancreatic cancer

The POLO study[54] showed that maintenance therapy with olaparib significantly improved PFS in patients with metastatic PDAC and germline BRCA1/2 mutations that ...

Short- and long-term efficacy of olaparib combined with ... - PMC

Conclusions: Olaparib combined with chemotherapy enhances short- and long-term efficacy, improves immune function, and prolongs survival in advanced TNBC ...

Clinical Trials

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NCT07283705 | A Phase II Study Evaluating BMS-986504 ...

Cohort 1: To evaluate the safety and tolerability of BMS-986504 in combination with neoadjuvant/adjuvant chemotherapy and as maintenance therapy in participants ...

Targeting MTAP Loss in Pancreatic and Biliary Tract Cancers

Similarly, in the first-in-human phase 1/2 trial of another PRMT5 inhibitor BMS-986504, 152 patients with MTAP-deleted tumors were treated, ...