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A Phase 1/2 Open-Label, Multicenter, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BH-30643 in Subjects with Locally Advanced or Metastatic NSCLC Harboring EGFR And/or HER2 Mutations (SOLARA)

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Trial Profile

A Phase 1/2 Open-Label, Multicenter, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BH-30643 in Subjects with Locally Advanced or Metastatic NSCLC Harboring EGFR And/or HER2 Mutations (SOLARA)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 24 Sep 2026

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At a glance

  • Drugs BH 30643 (Primary)
  • Indications Non-small cell lung cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms SOLARA
  • Sponsors BlossomHill Therapeutics

Most Recent Events

  • 18 Sep 2026 According to BlossomHill Therapeutics media release, the company is looking forward to end-of-phase 1 meeting with the FDA in Q4 2026. Updated Phase 1 data, including C797S durability expected in 1H 2027 and updated Phase 1 data on TKI-naive durability and initial chemo combo cohort data expected in 2H 2027. first patient dosing in phase II pivotal trial expected in Q1 2026.
  • 15 Sep 2026 According to BlossomHill Therapeutics media release, the company plans to plans to initiate a global Phase 2 study targeting EGFR C797S-positive NSCLC in Q1 2027.
  • 15 Sep 2026 According to BlossomHill Therapeutics media release, The data from this trial were highlighted in a mini-oral presentation at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer in Seoul, South Korea.

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