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A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-8520 in Subjects With Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - The ONKORAS-101 Study

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Trial Profile

A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-8520 in Subjects With Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - The ONKORAS-101 Study

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 03 Oct 2025

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At a glance

  • Drugs BBO 8520 (Primary) ; Pembrolizumab (Primary)
  • Indications Colorectal cancer; Non-small cell lung cancer
  • Focus Adverse reactions; First in man
  • Acronyms ONKORAS-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.
  • 16 Jan 2025 Planned number of patients changed from 229 to 250.
  • 14 Oct 2024 Planned number of patients changed from 160 to 229.

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