A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)

Official Summary

First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 392 participants

Interventions

• DRUG: BBO-10203 — Participants will receive assigned dose of BBO-10203 orally once daily
• DRUG: Trastuzumab — Participants will receive trastuzumab as infusion or subcutaneous injection every 21 days
• DRUG: Fulvestrant — Patients will receive Fulvestrant as an intramuscular injection every 28 days (additional dose on C1D15)
• DRUG: Ribociclib — Patients will receive Ribociclib orally once a day (21 days on treatment, 7 days off)
• DRUG: FOLFOX — Patients will receive FOLFOX as infusion every 14 days

Primary Outcomes

• Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BBO-10203 as a single agent (Up to approximately 5 years)
• Percentage of patients with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) (Up to approximately 5 years)
• Recommended BBO-10203 dose in combination with trastuzumab, fulvestrant +/- ribociclib, and FOLFOX + bevacizumab (Up to approximately 5 years)

Secondary Outcomes

• Clinical benefit rate (CBR) as assessed by RECIST v1.1. (Up to approximately 5 years)
• Duration of response (DOR) as assessed by RECIST v1.1. (Up to approximately 5 years)
• Progression-free survival (PFS) as assessed by RECIST v1.1 (Up to approximately 5 years)
• Overall survival (OS) (Up to approximately 5 years)
• Area under the concentration-time curve (AUC (Predose (within 30 minutes) of C1D1 until up to approximately 5 years)

Trial Locations

• City of Hope Comprehensive Cancer Center, Duarte, California, United States
• University of California Los Angeles, Los Angeles, California, United States
• University of California San Diego Moores Cancer Center, San Diego, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
• Moffitt Cancer Center, Tampa, Florida, United States
• Indiana University Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States
• Massachusetts General Hospital, Boston, Massachusetts, United States
• Dana-Farber Cancer Insitute, Boston, Massachusetts, United States
• St. Lukes Hospital of Kansas City, Kansas City, Missouri, United States
• Washington University School of Medicine, St Louis, Missouri, United States
• ...and 10 more locations

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