Study #2024-1781
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)
MD Anderson Study Status
Enrolling
Treatment Agent
BH-30643
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. Phase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643. 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.
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
NSCLC (Advanced Non-small Cell Lung Cancer)
Study phase:
Physician name:
Xiuning Le
Department:
Thoracic/Head & Neck Medical Oncology
For general questions about clinical trials:
1-877-632-6789
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