Actively Recruiting
Phase 1 Study of BG-75098 Alone and with BGB-43395 and Fulvestrant in Adults with Advanced Solid Tumors
Led by BeOne Medicines · Updated on 2026-07-10
105
Participants Needed
21
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, how the body processes and responds to BG-75098 alone and combined with BGB-43395 and fulvestrant in adults with advanced solid tumors. This Phase 1a1b study aims to understand these effects and preliminary antitumor activity in participants with advanced, metastatic, or unresectable solid tumors, including those who have progressed after other treatments. The study has two phases Phase 1a involves dose escalation where increasing doses of BG-75098 are tested alone and in combination with BGB-43395 and fulvestrant. Phase 1b involves dose expansion where participants receive BG-75098 at the recommended dose from Phase 1a either alone or combined with the other drugs. BG-75098 and BGB-43395 are given orally, while fulvestrant is given by injection. Participants will be monitored for adverse events, drug levels in the blood, and tumor response up to approximately two years. Assessments include pharmacokinetics, pharmacodynamics, and measuring tumor shrinkage or control. Safety and tolerability will be followed from the first dose through 30 days after the last dose, with ongoing evaluations during treatment cycles and follow-up periods up to two years.
CONDITIONS
Brief Title
A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors
Research Team
S
Study Director
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