drugset
drugset / Trial / NCT07366840

RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure

NCT07366840 ↗

Phase 2/3 Not yet recruiting 268 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety and efficacy of RC48 (a HER2 antibody drug conjugate with MMAE payload) in combination with gemcitabine or capecitabine (with or without trastuzumab/inetetamab), for treatment of patients with HER2-positive advanced breast cancer (ABC) who have developed disease progression or intolerance to prior therapy with a topoisomerase I inhibitor antibody-drug conjugate (TOP1i-ADC).

Timeline

Start
2026-01-16
Primary completion
2028-01-16
Completion
2029-01-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Disitamab Vedotin Monoclonal antibody 2 mg/kg Intravenous
Subject Inetetamab Monoclonal antibody 6 mg/kg Intravenous
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous

Indications

HER2 positive breast carcinoma