NCT07131345Not yet recruitingPhase 1/2
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 · Last updated 20 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- First submitted
- 14 Jun 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- National Cancer Center, China
- Diseases
- Mesothelioma, Lung cancer
- NCT number
- NCT07131345
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 55
- From 1 Sept 2025 to the primary completion date, 31 Oct 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior CTLA-4 inhibitors prohibited; prior PD-1/PD-L1 allowed unless discontinued for immune toxicity
Other
- Immunomodulators within 14 days (e.g., thymosin, interleukin-2, interferon)
- Significant cardiovascular history within 6 months
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.