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NCT06875076PHASE2RECRUITING

Multicenter Single-Arm Study of Ivonescimab (AK112) Combined with Chemotherapy in Pretreated Pleural Mesothelioma

Efficacy and Safety of Ivonescimab (AK112) in Combination with Chemotherapy for the Treatment of Pretreated Pleural Mesothelioma: a Phase II Multicenter, Single-Arm Clinical Trial

Sponsor: The First Hospital of Jilin University

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type
INTERVENTIONAL
Conditions
Pretreated Pleural Mesothelioma
Interventions
Ivonescimab Combined With Chemotherapy
Enrollment
25 participants
Primary completion
Jan 2028
Study completion
Dec 2029
First posted
Mar 2025
Last updated
Mar 2025

Primary Endpoints (CT.gov)

objective response rate (ORR)

Time frame: From enrollment to the end of treatment at 3 months

Secondary Endpoints

progression-free survival (PFS)

overall survival (OS)

adverse effect

Eligibility Criteria

Inclusion Criteria: 1. Asian ethnicity, aged 18-75, ECOG 0-1; 2. Histologically confirmed malignant pleural mesothelioma; 3. Progression after ≥1 and ≤2 prior systemic therapies (platinum-based chemotherapy, immunotherapy combinations, or anti-angiogenic therapy); 4. ≥1 measurable lesion (modified RECIST 1.1); 5. Adequate organ function (hemoglobin ≥90g/L, neutrophils ≥1.5×10⁹/L, creatinine clearance ≥50ml/min). Exclusion Criteria: 1. History of other malignancies within 5 years prior to enrollment, except cured basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ with radical resection. Patients diagnosed with other malignancies or lung cancer more than 5 years prior to enrollment require pathological/cytological confirmation of recurrent lesions. 2. Radiologically confirmed tumor encasement of major blood vessels, necrosis, or cavitation with significant bleeding risk as judged by the investigator. Tumor invasion of adjacent critical organs/vessels (

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov