NCT06625775

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

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 392 (estimated)
• Sponsor: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label, multi-center Phase 1a/1b study designed to evaluate the safety, tolerability, preliminary antitumor activity, and PK of BBO-10203 as a single agent and in combination with Trastuzumab, Fulvestrant +/- Ribociclib, or FOLFOX + Bevacizumab in patients with locally advanced unresectable or metastatic (ie, advanced) solid tumors. The study includes a dose escalation phase and an expansion phase.

Conditions

• Solid Tumor, Adult
• Metastatic Breast Cancer
• Advanced Breast Cancer
• HER2 Mutation-Related Tumors
• HER2-positive Metastatic Breast Cancer
• KRAS Mutant Metastatic Colorectal Cancer
• Metastatic Lung Cancer
• Metastatic Colorectal Cancer
• Advanced Lung Cancer
• HR-positive, HER2-negative Advanced Breast Cancer
• HER2-positive Advanced Breast Cancer

Interventions

Type	Name	Description
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
DRUG	Bevacizumab	Patients will receive bevacizumab as infusion every 28 days

Timeline

• Start date: 2024-10-29
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2024-10-03
• Last updated: 2026-04-13

Locations

36 sites across 4 countries: United States, Australia, France, Spain

Regulatory

• FDA-regulated drug study