Phase I/IIa Study of H002 in NSCLC With Active EGFR Mutation

This is a phase I/IIa, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of H002 when given orally in patients with active EGFR mutation locally advanced or metastatic non-small cell lung cancer (NSCLC). The study will contain two parts: Part A is dose escalation phase (i.e., Phase I) and Part B is dose expansion phase (i.e., Phase IIa).

Trial Details

NCT ID
NCT05519293
Phase
PHASE1 / PHASE2
Sponsor
RedCloud Bio
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • H002
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • New York, New York, United States|40.71427,-74.00597
  • Fairfax, Virginia, United States|38.84622,-77.30637

Key Eligibility Criteria

  • Males or females aged ≥ 18 years at time of signing informed consent form (ICF).
  • Histological or cytological confirmed diagnosis of unresectable locally advanced or metastatic NSCLC.
  • Subjects must have NSCLC harboring one or more active EGFR mutations known to be associated with EGFR-TKI sensitivity (including, but not limited t…
  • Part A: All subjects may provide tumor sample to central laboratory to analyze the EGFR mutation status according to their own willingness;

For full eligibility, visit ClinicalTrials.gov.

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