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Study of Iparomlimab and Tuvonralimab Plus Chemotherapy in Malignant Mesothelioma
Sponsor: National Cancer Center, China
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.
Official title: A Single-Arm, Multicenter, Open-Label Phase Ib/II Clinical Study Exploring the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection in Combination With Chemotherapy for the Treatment of Malignant Mesothelioma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
55
Start Date
2025-09-01
Completion Date
2027-07-01
Last Updated
2025-08-20
Healthy Volunteers
No
Conditions
Interventions
iparomlimab and tuvonralimab (Dual PD-1/CTLA-4 blockade) + chemotherapy
Novel Bispecific Checkpoint Inhibition: QL1706(iparomlimab and Tuvonralimab) was generated by using MabPair, a new technological platform that enables the production of two antibodies close to their natural forms from a single host cell line and is manufactured as one product. QL1706 contains a mixture of anti-PD-1 IgG4 and anti-CTLA-4 IgG1 that were produced together in a fixed ratio. Each antibody was individually optimized to achieve desirable target coverage and antibody effector functions. Chemotherapy for first-line treatment (pemetrexed plus cisplatin or carboplatin ) Chemotherapy for second-line treatment (pemetrexed, gemcitabine or vinorelbine)