A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
Key facts
- Where
- Edmonton and Toronto, CanadaSee the 2 sites
- Phase
- Phase 1/2
Where in Canada
- Cross Cancer InstituteEdmonton, CanadaTaking people
- Princess Margaret Cancer CentreToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BlossomHill Therapeutics
- Trial code
- NCT06706076
- Record updated
- 4 November 2026
- Original description
This Phase1/2, open label, multicenter study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with NSCLC having EGFR and/or HER2 mutations.Read full original descriptionShow less
A Phase 1/2 Open-Label, Multicenter, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BH-30643 in Adult Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations (SOLARA)
This Phase1/2, open label, multicenter study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with NSCLC having EGFR and/or HER2 mutations.
Phase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643, both as a monotherapy and in combination with chemotherapy.
Phase 2 will further evaluate the antitumor efficacy and safety in specified cohorts determined by EGFR/HER2 mutation subtypes and/or treatment history at the RP2D, as well as the population PK.
Inclusion: ≥ 18 years or legal adult; Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC with EGFR or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21; Has at least 1 measurable target extracranial lesion according to RECIST v1.1; Eastern Cooperative Oncology Group Performance Status ≤ 1; Has a life expectancy of ≥ 3 months; Has adequate hematologic, hepatic, and renal function; The above are a summary; other Inclusion Criteria details may apply.
Exclusion: History of any concurrent malignancy within the previous 2 years; Unresolved toxicities from prior therapies; Any significant and uncontrolled medical condition, such as infection; Active or history of interstitial lung disease from any cause; Clinically significant cardiovascular event within 6 months or significant history of major organ; The above are a summary; other Exclusion Criteria details may apply; Known other oncogenic driver alterations (eg, moderate or high MET amplification) or histological transformation (eg, to small cell carcinoma, etc.).