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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: 24 Dec 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

  • 10 Dec 2025 According to a BridgeBio Oncology Therapeutics media release, company will also present a trial in progress poster from this study at the San Antonio Breast Cancer Symposium (SABCS).
  • 30 Oct 2025 According to a BridgeBio Oncology Therapeutics media release, data from this trial will be presented at the San Antonio Breast Cancer Symposium (SABCS) being held December 9-12, 2025, in San Antonio, Texas.
  • 25 Oct 2025 According to a BridgeBio Oncology Therapeutics media release, initial clinical data from this study are expected in the first half of 2026.

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