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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)

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Trial Profile

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 of Trial: Phase I

Latest Information Update: 30 Jun 2025

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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

  • 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.
  • 30 Oct 2024 According to a BridgeBio Oncology Therapeutics media release, first patient has been dosed with BBO-10203 in the BREAKER-101 trial.

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