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A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations

Study acronym: SOLARA
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment increased: 266 → 675 participantsv25 Show 5 more changesShow less
    • Trial arms changed: 2 → 3
    • Interventions: BH-30643 (Drug), BH-30643 (Drug) to BH-30643 (Drug), BH-30643 (Drug), BH-30643 combo therapy with Carboplatin/Pemetrexed (Drug)
    • Eligibility criteria shortened, about 28 words
    • Secondary endpoints: 14 to 13
    • Study sites revised (42)
  2. Study sites: 41 to 42v24
  3. Trial sites expanded: 38 → 41 locationsv23
  4. Study sites: 37 to 38v22
  5. Study sites: 35 to 37v21
Show 19 earlier versionsHide 19 earlier versions
  1. Study sites: 33 to 35v20
  2. Study sites: 30 to 33
    • Study description shortened, about 17 words
    v19
  3. Study sites: 27 to 30v18
  4. Study sites: 24 to 27v17
  5. Study sites: 21 to 24v16
  6. Study sites: 19 to 21v15
  7. Study sites: 18 to 19v14
  8. Study sites: 15 to 18v13
  9. Study sites: 13 to 15v12
  10. Study sites: 11 to 13v11
  11. Study sites: 10 to 11v10
  12. Study sites: 9 to 10v9
  13. Study sites: 8 to 9v8
  14. Study sites: 7 to 8v7
  15. Study sites: 5 to 7v6
  16. Study sites: 4 to 5v5
  17. Study sites: 2 to 4v4
  18. Study sites: 1 to 2
    • Start date changed from estimate of Jan 2025 to Jan 9, 2025
    v3
  19. Start date: Dec 2, 2024 to Jan 2025v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06706076
Lead Sponsor BlossomHill Therapeutics
Conditions
(from sponsor)		 NSCLC (Advanced Non-small Cell Lung Cancer)
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 675 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov