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Clinical Trial NCT07131345 for Malignant Mesothelioma, Mesothelioma is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Study of Iparomlimab and Tuvonralimab Plus Chemotherapy in Malignant Mesothelioma Phase 1, Phase 2 55 Combination Therapy

Not yet recruiting
Clinical Trial NCT07131345 is designed to study Treatment for Malignant Mesothelioma, Mesothelioma. This Phase 1 Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 1 September 2025 until the study accrues 55 participants. Led by National Cancer Center, China, this study is expected to complete by 1 July 2027. The latest data from ClinicalTrials.gov was last updated on 20 August 2025.
Brief 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...Show More
Detailed Description
Study Rationale Malignant mesothelioma (MM) is a rare and aggressive cancer primarily associated with asbestos exposure. Despite advances in treatment, the prognosis remains poor, with a median overall survival (OS) of approximately 12-18 months for advanced disease. Current standard therapies include platinum-based chemotherapy combined with pemetrexed, immune checkpoint inhibitors (ICIs) such as nivolumab plus ipil...Show More
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

Conditions
Malignant MesotheliomaMesothelioma
Other Study IDs
  • NCC5281
NCT ID Number
NCT07131345
Start Date (Actual)
2025-09-01
Last Update Posted
2025-08-20
Completion Date (Estimated)
2027-07-01
Enrollment (Estimated)
55
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Not yet recruiting
Keywords
Malignant Mesothelioma
iparomlimab and tuvonralimab
immunotherapy
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalArm: 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.
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...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
ORR
Objective Response Rate，Proportion of participants achieving complete response (CR) or partial response (PR) per modified RECIST 1.1 for mesothelioma
From enrollment to the end of treatment at 8 weeks
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • Subjects must provide informed consent prior to initiating any study-specific procedures.

  • Male or female subjects aged ≥18 and ≤75 years.

  • Histologically/cytologically confirmed malignant mesothelioma (MM), including malignant pleural mesothelioma (PM) and malignant peritoneal mesothelioma (PeM).

  • Subjects with MM unsuitable for radical resection and/or radiotherapy per AJCC 8th Edition.

  • Subjects who received neoadjuvant/adjuvant chemotherapy for radical surgery completed >6 months prior to current recurrent disease diagnosis, not counted in subsequent treatment lines.

  • Prior systemic anti-tumor therapy requirements:

    • Safety run-in phase: ≥1 prior anti-tumor therapy line (maximum 3 lines)
    • Phase II first-line cohort: No prior systemic anti-tumor therapy
    • Phase II second-line cohort: Only 1 prior systemic anti-tumor therapy line

  • ECOG performance status 0-2.

  • Investigator-assessed life expectancy >3 months.

  • Adequate hematological parameters.

  • Prior CTLA-4 inhibitors prohibited; prior PD-1/PD-L1 allowed unless discontinued for immune toxicity
  • Immunomodulators within 14 days (e.g., thymosin, interleukin-2, interferon)
  • Significant cardiovascular history within 6 months
National Cancer Center, China logoNational Cancer Center, China
Study Responsible Party
Puyuan Xing, Principal Investigator, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Cancer Center, China
Study Central Contact
Contact: Puyuan Xing, MD, 8618611417207, [email protected]
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