Study of Iparomlimab and Tuvonralimab Plus Chemotherapy in Malignant Mesothelioma

NCT07131345 | Not Yet Recruiting Phase 1

• 1 other identifier: NCC5281
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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 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

Malignant Mesothelioma; Mesothelioma

Keywords

Malignant Mesothelioma; iparomlimab and tuvonralimab; immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Arm: Iparomlimab and Tuvonralimab Combined with Chemotherapy

EXPERIMENTAL

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.

Drug: iparomlimab and tuvonralimab (Dual PD-1/CTLA-4 blockade) + chemotherapy

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)

Also known as: QL1706+chemotherapy

Arm: Iparomlimab and Tuvonralimab Combined with Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, China: lead
• Qilu Pharmaceutical Co., Ltd.: collaborator
• Affiliated Cancer Hospital of Zhengzhou University: collaborator
• Beijing Chest Hospital, Capital Medical University: collaborator
• The Affiliated Hospital of Inner Mongolia Medical University: collaborator
• Shaanxi Provincial Cancer Hospital: collaborator

MeSH Terms

Conditions

Mesothelioma, Malignant; Mesothelioma

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Puyuan Xing, MD

  National Cancer Center, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Puyuan Xing, MD

CONTACT

8618611417207; xingpuyuan@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: August 20, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share