A Phase 1 interventional study of Ivonescimab Combined With Chemotherapy in Malignant Pleural Mesothelioma, Advanced, sponsored by Ruijin Hospital. Active, not recruiting at 2 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, Interventional, and Treatment
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.
Ivonescimab is administered at 3, 10, or 20 mg/kg every 3 weeks in combination with pemetrexed 500 mg/m² and cisplatin 75 mg/m² or carboplatin AUC 5 for 4 to 6 cycles. Dose escalation follows a conventional 3+3 design, with dose-limiting toxicities assessed during the first 28 days. Safety, tolerability, and preliminary antitumor activity are evaluated to support dose selection for subsequent dose expansion. 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 enrollment of 9 is below the median of 37 across 336 interventional studies indexed under Mesothelioma, Malignant.
Browse Mesothelioma, Malignant studies →Ruijin Hospital is the lead sponsor of 668 studies on the registry; 377 are open to participants now.
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Exclusion Criteria:
A single experimental arm consisting of sequential ivonescimab dose-escalation cohorts using a conventional 3+3 design.
Drug: Ivonescimab Combined With Chemotherapy
Drug page: Ivonescimab
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.
Dose-Limiting Toxicities
Incidence of protocol-defined dose-limiting toxicities.
Time frame: From the first dose through Day 28
Treatment-Emergent Adverse Events
Incidence and severity of treatment-emergent adverse events according to CTCAE v5.0.
Time frame: From the first dose through the last available safety assessment, up to 24 months.
Objective Response Rate
Proportion of participants with a best overall response of complete response or partial response according to modified RECIST for malignant pleural mesothelioma.
Time frame: From the first dose through the last available tumor response 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 RECIST 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 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 to death from any cause.
Time frame: From the first dose until death from any cause, assessed up to 24 months.
Plan to share: No
No publications or documents are linked to this record.
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 active, not 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