Phase 1a1b Study of BBO-10203 Alone and With Other Treatments for Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating BBO-10203, a drug that blocks PI3KRAS, in patients with advanced solid tumors including breast, colorectal, and lung cancers. This Phase 1a1b open-label study aims to assess the safety, tolerability, pharmacokinetics, and early signs of antitumor activity of BBO-10203 alone and combined with other cancer treatments. The study includes a dose escalation phase followed by an expansion phase to explore different combinations and doses. Participants receive BBO-10203 tablets orally once daily, either alone or combined with trastuzumab, fulvestrant with or without ribociclib, or FOLFOX plus bevacizumab, depending on their cancer type. Different cohorts focus on specific advanced cancers such as HER2-positive breast cancer, HR-positive HER2-negative breast cancer, KRAS-mutant colorectal cancer, and advanced lung cancer. Treatments like trastuzumab and bevacizumab are given by infusion or injection at set intervals, while other drugs are given orally or by injection on scheduled days. Throughout the study, participants undergo evaluations to monitor safety and drug effects, including measuring adverse events, dose limits, and drug levels in the blood. Researchers also assess tumor response using standard imaging criteria, survival outcomes, and clinical benefit over up to approximately five years. This long monitoring period helps understand the drugs effects and guides future dosing recommendations.

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors