Multicenter Single-Arm Study of Ivonescimab (AK112) Combined with Chemotherapy in Pretreated Pleural Mesothelioma
Summary
This study is a prospective, multicenter, single-arm, Phase II clinical trial evaluating the efficacy and safety of ivonescimab (AK112) combined with chemotherapy in patients with pleural mesothelioma who failed prior immunotherapy, anti-angiogenic therapy, or chemotherapy. The regimen consists of a treatment phase (ivonescimab 20mg/kg combined with pemetrexed 500mg/m²/gemcitabine 1000mg/m²/vinorelbine 25mg/m² every 21 days for 4 cycles) followed by a maintenance phase (ivonescimab monotherapy 20mg/kg every 21 days until disease progression, intolerance, or up to 2 years).The trial plans to enroll 25 patients, with the primary endpoint being objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), overall survival (OS), and safety profiles. Exploratory endpoints investigate biomarkers such as tertiary lymphoid structures, tumor-infiltrating lymphocytes, and macrophage polarization within the tumor microenvironment.
Timeline
- Start
- 2025-03-08
- Primary completion
- 2028-01
- Completion
- 2029-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ivonescimab | Monoclonal antibody | 20 mg/kg | — |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Background | Pemetrexed | Small molecule | 500 mg/m2 | — |
| Background | Vinorelbine | Small molecule | 25 mg/m2 | — |