A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors

Launched by BRISTOL-MYERS SQUIBB · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BMS-986500 for patients with advanced solid tumors, which include types like advanced breast cancer and advanced ovarian cancer. The trial aims to see how well BMS-986500 works on its own and in combination with other treatments, particularly for those who have already received a specific type of therapy called a CDK4/6 inhibitor.

To participate in this study, you need to be at least 18 years old and have a confirmed diagnosis of an advanced solid tumor that cannot be surgically removed. You should also have measurable disease, meaning your cancer can be tracked for changes. It's important that you have a good performance status, which means you are relatively active and not too limited by your illness. However, if you have certain conditions like active brain metastasis (cancer spread to the brain) or significant heart problems, you may not be eligible. Participants will have regular check-ups and monitoring during the trial to assess how the treatment is affecting their condition. This trial is not yet recruiting participants, so there will be more information available when it begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants must be ≥ 18 years of age.
• • Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy.
• • Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• • Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1.
• • For Part 2A only, participants must have CCNE1-amplified ovarian cancer
• Exclusion Criteria:
• • Participants must not have an active brain metastasis.
• • Participants must not have impaired cardiac function or clinically significant cardiac disease.
• • Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months.
• • Participants must not have Grade ≥ 2 peripheral neuropathy.
• • Other protocol-defined Inclusion/Exclusion criteria apply.