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)
Latest Information Update: 07 Oct 2025
At a glance
- Drugs BBO 10203 (Primary) ; Bevacizumab (Primary) ; Fluorouracil (Primary) ; Folinic acid (Primary) ; Fulvestrant (Primary) ; Oxaliplatin (Primary) ; Ribociclib (Primary) ; Trastuzumab (Primary) ; Trastuzumab (Primary)
- Indications Advanced breast cancer; Colorectal cancer; HER2 negative breast cancer; HER2 positive breast cancer; Non-small cell lung cancer
- Focus Adverse reactions; First in man
- Acronyms BREAKER-101
- Sponsors BridgeBio Oncology Therapeutics
Most Recent Events
- 11 Aug 2025 According to a BridgeBio Oncology Therapeutics media release, combining approx. $120 million from the former Helix II trust account (reflecting a final redemption rate of approximately 39% which is the second lowest redemption rate for a biotech de-SPAC transaction since 2022) with the PIPE provides approx. $382 million in gross proceeds and net proceeds will be used to accelerate the development of BBOT's pipeline of clinical-stage RAS-targeted oncology drug candidates including this trial.
- 24 Jun 2025 Planned number of patients changed from 153 to 392.
- 30 Oct 2024 According to a BridgeBio Oncology Therapeutics media release, Dr. Minal Barve is the Principal Investigator of the trial.
