A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation

RemeGen

Status and phase

Not yet enrolling

Phase 2

Phase 1

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Pyrotinib

Drug: RC48-ADC

Study type

Interventional

Funder types

Industry

Identifiers

NCT05745740

RC48-C021

Details and patient eligibility

About

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.

Enrollment

26 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.