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Study of Iparomlimab and Tuvonralimab Plus Chemotherapy in Malignant Mesothelioma

NCT07131345 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-08-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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)

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Affiliated Cancer Hospital of Zhengzhou University

    collaborator UNKNOWN

  • Beijing Chest Hospital, Capital Medical University

    collaborator OTHER

  • The Affiliated Hospital of Inner Mongolia Medical University

    collaborator OTHER

  • Shaanxi Provincial Cancer Hospital

    collaborator OTHER

  • National Cancer Center, China

    lead OTHER

Principal Investigators

  • Puyuan Xing, MD · National Cancer Center, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07131345 on ClinicalTrials.gov