Primary Outcome Measures
- ORR
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
