Phase 1 Study of BMS-986500 Alone or with Other Drugs for Advanced Solid Tumors and Breast Cancer Previously Treated with CDK46 Inhibitors

What this Trial Is About

Researchers are evaluating BMS-986500 as a treatment for people with advanced solid tumors, including advanced breast and ovarian cancers. This Phase 1 study investigates BMS-986500 alone and in combination with other drugs in patients who have previously been treated with CDK46 inhibitors for breast cancer. The study aims to understand how this drug works and its safety for these advanced cancers. Participants receive BMS-986500 either as a single drug or combined with Palbociclib and Fulvestrant, with doses given on specified days. The study includes multiple parts dose escalation for both monotherapy and combination therapy, a pharmacodynamic sub-study for monotherapy, and dose expansion phases for both treatment types. Each part explores different dosing strategies and treatment effects. During the study, participants are closely monitored for side effects, including dose-limiting toxicities and serious adverse events up to 28 days after the last dose. Blood tests measure how the drug is processed in the body over about two years. The study tracks safety and drug levels while participants receive treatment and during follow-up, with the study lasting until 2028. Participants undergo assessments for disease status and overall health throughout the trial.

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