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Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Sponsor: Ruijin Hospital
Summary
This Phase 1b/2, open-label, multicenter, single-arm study evaluates the safety and efficacy of ivonescimab in combination with pemetrexed and platinum-based chemotherapy as first-line treatment for advanced malignant pleural mesothelioma. Phase 1b evaluates the candidate recommended Phase 2 dose (RP2D), followed by Phase 2 evaluation at the confirmed RP2D.
Official title: A Phase 1b/2, Open-Label, Multicenter, Single-Arm Study of Ivonescimab in Combination With Pemetrexed and Platinum-Based Chemotherapy as First-Line Treatment in Patients With Advanced Malignant Pleural Mesothelioma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2026-11-01
Completion Date
2028-11-30
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
Ivonescimab Combined With Chemotherapy
In Phase 1b, ivonescimab 20 mg/kg is administered intravenously every 3 weeks (Q3W) in combination with pemetrexed 500 mg/m² and cisplatin 75 mg/m² or carboplatin AUC 5 for 4 to 6 cycles. In Phase 2, ivonescimab is administered at the confirmed RP2D with the same chemotherapy regimen, followed by maintenance treatment with ivonescimab with or without pemetrexed Q3W.
Locations (3)
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China