Study of Iparomlimab and Tuvonralimab Plus Chemotherapy in Malignant Mesothelioma

Sponsor
National Cancer Center, China
Study ID
NCT07131345
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Malignant Mesothelioma
  • Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • iparomlimab and tuvonralimab (Dual PD-1/CTLA-4 blockade) + chemotherapy — DRUG
    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)

Study Details

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.

Key Dates

First listed
Aug 20, 2025
Start date
Sep 1, 2025
Status verified
Aug 2025
Primary completion
Oct 31, 2026
Completion
Jul 1, 2027

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm: Iparomlimab and Tuvonralimab Combined with Chemotherapy
    Patients will receive Iparomlimab and Tuvonralimab (5 mg/kg) plus chemotherapy (pemetrexed and platinum drugs) every 3 weeks for 4-6 cycles, followed by maintenance therapy with Iparomlimab and Tuvonralimab for up to 2 years.

Primary Outcome Measure

ORR [ Time Frame: From enrollment to the end of treatment at 8 weeks ]

Central Contacts

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