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

Required: EGFR activating mutation

NSCLC harboring one or more active EGFR mutations known to be associated with EGFR-TKI sensitivity (including, but not limited to Del19 and L858R)

Required: EGFR exon 19 deletion

including, but not limited to Del19 and L858R

Required: EGFR L858R

including, but not limited to Del19 and L858R

Required: EGFR C797S

subjects must have NSCLC harboring EGFR C797S mutation (Part B)

Excluded: EGFR exon 20 insertion

Subjects with EGFR exon 20 insertion mutations only [excluded]

Must have received: third-generation EGFR TKI (osimertinib)

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

Cannot have received: EGFR TKI

Exception: within 8 days or approximately 5 × t1/2 prior to the first dose of H002, whichever is longer

Prior treatment with an EGFR-TKI within 8 days or approximately 5 × t1/2 prior to the first dose of H002, whichever is longer

Cannot have received: immunotherapy or biotherapy

Exception: within 4 weeks prior to the first dose of H002

Prior treatment with immunotherapy or biotherapy within 4 weeks prior to the first dose of H002

Cannot have received: radiotherapy

Exception: palliative radiotherapy completed at least 2 weeks prior to the first dose of H002 can be enrolled; otherwise, radiotherapy within 4 weeks prior to the first dose of H002

Radiotherapy (palliative radiotherapy is completed at least 2 weeks prior to the first dose of H002 can be enrolled) within 4 weeks prior to the first dose of H002

Cannot have received: herbal therapy with anti-tumor effects

Exception: within 2 weeks prior to the first dose of H002

Herbal therapy that has anti-tumor effects within 2 weeks prior to the first dose of H002

Cannot have received: mitomycin (mitomycin)

Exception: within 6 weeks prior to the first dose of H002

Mitomycin and nitrosourea within 6 weeks prior to the first dose of H002

Cannot have received: nitrosourea (nitrosourea)

Exception: within 6 weeks prior to the first dose of H002

Mitomycin and nitrosourea within 6 weeks prior to the first dose of H002

Cannot have received: oral fluorouracil (tegafur, capecitabine)

Exception: within 2 weeks prior to the first dose of H002

Oral fluorouracil such as tegafur and capecitabine within 2 weeks prior to the first dose of H002

Cannot have received: chemotherapy

Exception: except for mitomycin, nitrosourea, and fluorouracil oral drugs; within 4 weeks or approximately 5 × t1/2 prior to the first dose of H002, whichever is longer

Chemotherapy (except for mitomycin, nitrosourea, and fluorouracil oral drugs), or other anti-tumor drugs for the treatment of NSCLC within 4 weeks or approximately 5 × t1/2 prior to the first dose of H002, whichever is longer

Cannot have received: treatment for EGFR C797S mutation (BTP-661411, TQB3804, BLU-945)

Prior marketed and/or investigational treatment for EGFR C797S mutation (including, but not limited to BTP-661411, TQB3804 and BLU-945)