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drugset / Trial / NCT07172217

The Efficacy and Safety RC48 Plus QL1706 in Second-Line Treatment of HER2-Expressing Recurrent CC

NCT07172217 ↗

Phase 2 Not yet recruiting 33 enrolled Qilu Hospital of Shandong University
NaSingle-groupOpen-labelTreatment

Summary

This is a single-arm study. The efficacy and safety of Disitamab Vedotin combined with Apalutamide and Toripalimab in the second-line treatment of HER2-expressing recurrent cervical cancer are evaluated based on the following indicators: Primary evaluation indicator: Objective Response Rate (ORR) Secondary evaluation indicators: Efficacy-related indicators: Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DOR), Overall Survival (including median Overall Survival \[mOS\] and 1-year, 2-year, 3-year Overall Survival rates) Safety-related indicators: Adverse Events (AEs) and Serious Adverse Events (SAEs).

Timeline

Start
2025-10-01
Primary completion
2027-02-28
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Disitamab Vedotin Monoclonal antibody 2.5 mg/kg Intravenous
Subject QL1706 Monoclonal antibody 5 mg/kg Intravenous

Indications

No indication recorded.