On January 22, 2025 BlossomHill Therapeutics, Inc., a privately-held, clinical-stage biotechnology company focused on the design and development of small molecule medicines for treating cancer and autoimmune diseases, reported the first cohort of patients has been dosed in the SOLARA study (NCT06706076) (Press release, BlossomHill Therapeutics, JAN 22, 2015, View Source;and-HER2-Mutated-Non-Small-Cell-Lung-Cancer [SID1234649839]). SOLARA is a global, open label, dose escalation and expansion Phase 1/2 clinical trial assessing the safety, efficacy and tolerability of BH-30643 for locally advanced or metastatic non-small cell lung cancer (NSCLC) bearing EGFR or HER2 mutations.
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"EGFR-mutant lung cancer is one of the most common genomic subtypes of lung cancer globally and has been a major target of drug development in recent years, yet an unmet medical need remains for patients," said Dr. Geoff Oxnard, Chief Medical Officer of BlossomHill Therapeutics. "Our thesis is that the novel, macrocyclic design of BH-30643 will provide potent antitumor activity in a broader spectrum of EGFR-mutant lung cancers with reduced toxicity. Dosing the first Phase 1 patient cohort with BH-30643, our second molecule to enter the clinic, marks an important step toward our goal of providing patients with intentionally designed precision medicines."
About the SOLARA study
The Phase 1/2 SOLARA clinical trial evaluates BH-30643, a macrocyclic, reversible, mutant-selective OMNI-EGFR inhibitor for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) bearing EGFR or HER2 mutations. In preclinical studies, BH-30643 demonstrated potent antitumor activity spanning classical EGFR mutations (exon 19 deletions, L858R), atypical EGFR mutations (G719X, L861Q, S768I, etc.), exon 20 insertions, and HER2 mutations. The global study consists of a dose escalation part to identify Recommended Doses for Evaluation (RDE), followed by an expansion part to further evaluate BH-30643 across a range of EGFR and HER2 mutations. Additional details on the design and discovery of BH-30643 will be reported at an upcoming medical meeting.