An Open-label, Single-center, Phase Ib/II Study to Evaluate the Safety, Efficacy and Pharmacokinetics of RC48-ADC Combined With Pyrotinib in Local Advanced or Metastasis NSCLC With HER2 Mutation

RC48-C021

This study will evaluate the efficacy, safety and pharmacokinetics of RC48-ADC for injection combined with pyrotinib in subjects with local advanced or metastatic non-small cell lung cancer with HER2 mutation.

2024-04-01

2025-12-01

2025-12-01

Not yet recruiting

Early phase I

26

Inclusion Criteria: * Voluntary agreement to provide written informed consent. * Predicted survival ≥ 12 weeks. * According to UICC/AJCC 8th Edition, histologically and/or cytologically-confirmed, cannot be surgically removed, locally advanced or metastatic NSCLC. * Is willing and able to provide an adequate archival tumor tissue sample * Has relapsed from or is refractory to standard treatment and had received both platinum-based therapy and immunotherapy. * Measurable lesion according to RECIST 1.1. * Documented HER2 exon 20 insertion mutation. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Adequate organ function. * For female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive (such as an intrauterine device, contraceptives, or condoms) during study treatment and within 6 months after the end of study, the blood pregnancy test within 7 days of study enrollment must be negative and must be non-lactating. Male subjects: Patients who should be surgically sterilized or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study. * Willing and able to follow trial and follow-up procedures. Exclusion Criteria: * No known EGFR, ALK, ROS1, RET, NTRK, MET 14 or BRAF V600E mutation. * Patient has had previous treatment with HER2-targeted therapy prior to study participation. * History of major surgery within 4 weeks of planned start of trial treatment. * Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, or HIVAb positive. * Has received a live virus vaccine within 4 weeks of planned start of trial treatment. * NYHA Class III heart failure. * Suffering from active infection requiring systemic treatment. * Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD. * Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 26, 'type': 'ESTIMATED'}}

2023-11-27