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Safety and Preliminary Antitumor Activity of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Sponsor: Ruijin Hospital
Summary
This Phase 1a, open-label, dose-escalation study evaluates the safety, tolerability, and preliminary antitumor activity of ivonescimab in combination with pemetrexed and platinum-based chemotherapy as first-line treatment for advanced malignant pleural mesothelioma. Ivonescimab is evaluated at sequential dose levels of 3, 10, and 20 mg/kg using a 3+3 dose-escalation design.
Official title: A Phase 1a, Open-Label, Dose-Escalation 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
9
Start Date
2025-03-12
Completion Date
2028-11-30
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
Ivonescimab Combined With Chemotherapy
Ivonescimab is administered intravenously at sequential dose levels of 3, 10, and 20 mg/kg 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. Maintenance treatment with ivonescimab at the assigned dose with or without pemetrexed may be continued Q3W.
Locations (4)
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
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