A Phase I/IIa, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Anti-tumor Activity of H002 in Patients With Active EGFR Mutation Locally Advanced or Metastatic NSCLC
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).
• 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 to Del19 and L858R).
‣ Part A: All subjects may provide tumor sample to central laboratory to analyze the EGFR mutation status according to their own willingness;
⁃ Part B: All subjects must provide tumor sample to central laboratory to analyze the EGFR mutation status. And subjects must have NSCLC harboring EGFR C797S mutation.
• Note: Tumor sample can be either an archival sample or a sample obtained by pretreatment biopsy prior to H002 treatment.
• Subjects must have radiological documented disease progression while on a previous continuous treatment with osimertinib or another third-generation EGFR-TKI as well as disease progression on the last treatment administered prior to enrolling in the study.
• Presence of at least one measurable lesion according to RECIST v1.1 per investigator assessment.
• ECOG performance status of 0-1.
• Life expectancy ≥ 12 weeks.
• Adequate hematologic and organ function per protocol.
• Women of childbearing potential (WOCBP) and fertile males with WOCBP partners must use highly effective contraception per protocol throughout the study. WOCBP must have a negative serum and/or urine pregnancy test result within 7 days prior to the first dose of H002.
⁃ Signed ICF, and this must be obtained before the performance of any protocol-specific procedures.