drugset / Trial / NCT07131345

Summary

This clinical trial aims to investigate the effectiveness and safety of a new treatment combination-Iparomlimab and Tuvonralimab (QL1706, a dual-function antibody targeting PD-1 and CTLA-4) combined with chemotherapy-for patients with malignant mesothelioma (MM). MM is a rare and aggressive cancer often linked to asbestos exposure. Current treatments have limited success, and this study seeks to explore a potentially more effective and safer option. Study Design: Phase Ib (Safety Phase): 6 patients will receive the combination therapy to assess safety. If no major safety issues arise, the study will proceed to Phase II. Phase II (Efficacy Phase): 49 patients will be enrolled to evaluate treatment effectiveness. The study includes two groups for first-line treatment and second-line treatment.

Timeline

Start
2025-09-01
Primary completion
2026-10-31
Completion
2027-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject QL1706 Monoclonal antibody 5 mg/kg Intravenous
Background Carboplatin Small molecule 5 unknown
Background Cisplatin Other / unclassified 75 mg/m2
Background Gemcitabine Small molecule
Background Pemetrexed Small molecule 500 mg/m2
Background Vinorelbine Small molecule