Clinical trial · Interventional
Study of Iparomlimab and Tuvonralimab Plus Chemotherapy in Malignant Mesothelioma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Mesothelioma | Malignant Mesothelioma | ONTOLOGY_EXACT | 0.98 |
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iparomlimab and tuvonralimab (Dual PD-1/CTLA-4 blockade) + chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm: Iparomlimab and Tuvonralimab Combined with Chemotherapy
- description
- 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.
- interventionNames
- Drug: iparomlimab and tuvonralimab (Dual PD-1/CTLA-4 blockade) + chemotherapy
Primary outcomes (1)
- measure
- ORR
- timeFrame
- From enrollment to the end of treatment at 8 weeks
- description
- Objective Response Rate，Proportion of participants achieving complete response (CR) or partial response (PR) per modified RECIST 1.1 for mesothelioma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available