drugset
drugset / Trial / NCT06730932

A Prospective，Single Arm, Multicenter Clinical Study of BTLA Monoclonal Antibody JS004 (B/T Lymphocyte Attenuator Factor Monoclonal Antibody) in Combination With Toripalimab in Patients With Unresectable or Advanced Renal Cell Carcinoma Who Had Failed Previous Immunotherapy

NCT06730932 ↗

Phase 2 Not yet recruiting 31 enrolled RenJi Hospital
NaSingle-groupOpen-labelTreatment

Summary

This study is A prospective，single arm, multicenter clinical study of BTLA monoclonal antibody JS004 (B/T lymphocyte attenuator factor monoclonal antibody) in combination with toripalimab in patients with unresectable or advanced renal cell carcinoma who had failed previous immunotherapy Subjects will receive JS004（B/T lymphocyte attenuator factor monoclonal antibody） plus Toripalimab until disease progression, development of unacceptable toxic effects, death, a decision by the physician or patient to withdraw from the trial. The primary endpoint is ORR per RECIST v1.1 as assessed by investigators(continuous treatment for up to 2 years).

Timeline

Start
2025-10-30
Primary completion
2026-10-30
Completion
2027-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tifcemalimab Monoclonal antibody 200 mg Intravenous
Subject Toripalimab Monoclonal antibody 240 mg Intravenous

Indications

No indication recorded.