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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: 13 Oct 2025

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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

  • 22 Aug 2025 According to the BlossomHill Therapeutics Media Release, company has announced the first patient dosed in the expansion cohorts of the study. The expansion cohorts of this trial will assess single-agent objective response rate (ORR) of BH-30643 in NSCLC patients with diverse EGFR mutations.
  • 22 Jan 2025 According to the BlossomHill Therapeutics Media Release, first cohort of patients has been dosed in this study. and Additional details on the design and discovery of BH-30643 will be reported at an upcoming medical meeting.
  • 06 Jan 2025 Planned initiation date changed from 2 Dec 2024 to 1 Jan 2025.

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