A Phase 1/2 interventional study of Ivonescimab Combined With Chemotherapy in Malignant Pleural Mesothelioma, Advanced, sponsored by Ruijin Hospital. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Ruijin Hospital · Phase 1/2, Interventional, and Treatment
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.
In Phase 1b, ivonescimab 20 mg/kg, selected as the candidate RP2D based on prior Phase 1a results, is administered every 3 weeks in combination with pemetrexed 500 mg/m² and cisplatin 75 mg/m² or carboplatin AUC 5 for 4 to 6 cycles. Phase 1b further evaluates safety and preliminary efficacy and confirms the RP2D. In Phase 2, participants receive ivonescimab at the confirmed RP2D with the same chemotherapy regimen, followed by maintenance treatment with ivonescimab with or without pemetrexed every 3 weeks. Objective response rate (ORR) is the primary efficacy endpoint of Phase 2. Peripheral blood, pleural effusion, and pleural tissue samples will be collected for exploratory analyses.
418 studies on the registry are indexed under Mesothelioma, Malignant; 73 are open to participants now.
This study's planned enrollment of 78 is above the median of 37 across 336 interventional studies indexed under Mesothelioma, Malignant.
Browse Mesothelioma, Malignant studies →Ruijin Hospital is the lead sponsor of 667 studies on the registry; 376 are open to participants now.
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Exclusion Criteria:
A single experimental arm consisting of a Phase 1b fixed-dose expansion followed by a Phase 2 efficacy evaluation.
Drug: Ivonescimab Combined With Chemotherapy
Drug page: Ivonescimab
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.
Dose-Limiting Toxicities in Phase 1b
Incidence of protocol-defined dose-limiting toxicities during the Phase 1b dose-limiting toxicity evaluation period.
Time frame: From the first dose through Day 28.
Objective Response Rate
Proportion of participants with a best overall response of complete response or partial response according to modified Response for malignant pleural mesothelioma.
Time frame: From the first dose through the last available tumor response assessment, up to 24 months.
Treatment-Emergent Adverse Events
Incidence and severity of treatment-emergent adverse events graded according to the Common Terminology Criteria for Adverse Events, version 5.0.
Time frame: From the first dose through the last available safety assessment, up to 24 months.
Disease Control Rate
Proportion of participants with a best overall response of complete response, partial response, or stable disease according to modified Response Evaluation Criteria in Solid Tumors for malignant pleural mesothelioma.
Time frame: From the first dose through the last available tumor response assessment, up to 24 months.
Progression-Free Survival
Time from the first dose of study treatment to the first documented disease progression or death from any cause, whichever occurs first.
Time frame: From the first dose until disease progression or death from any cause, assessed up to 24 months.
Overall Survival
Time from the first dose of study treatment to death from any cause.
Time frame: From the first dose until death from any cause, assessed up to 24 months.
Duration of Response
Time from the first documented complete response or partial response to the first documented disease progression according to modified Response Evaluation Criteria in Solid Tumors for malignant pleural mesothelioma or death from any cause, whichever occurs first.
Time frame: From the first documented complete response or partial response until disease progression or death from any cause, assessed up to 24 months.
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ivonescimab