Clinical Trial

A Multicenter, Open-label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of B1962 Injection in the Treatment of Advanced Malignant Solid Tumors

Not Yet Recruiting Phase 2
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Summary
This is a multicenter, open-label Phase IIa clinical study to evaluate the efficacy and safety of B1962 in the treatment of ad-vanced solid tumors. The study consists of a Screening Period, a Treatment Period, and a Follow-up Period (EOT Visit, Safety Follow-up, and Survival Follow-up). Subjects who meet the inclusion criteria and do not meet the exclusion criteria at screening will enter the appropriate study co-hort according to tumor type and receive B1962 until unacceptable toxicity, radiographic disease progression, or withdrawal of the sub-ject for other reasons, whichever comes first, for a maximum of 24 months of treatment. Enrollment will be conducted according to three stages: Stage I: It is planned to enroll 5 patients in each of 8 cohorts (tumor type) to observe the safety and efficacy; Stage II: 1 \~ 2 cohorts are preferred to enroll 15 \~ 20 patients to observe the ef-ficacy and safety; Stage III: 1 cohort is finally preferred to continue enrollment until a total of no more than 60 patients are observed in this cohort to observe the efficacy and safety.
Trial Details
NCT Number NCT06724263
Lead Sponsor Tasly Biopharmaceuticals Co., Ltd.
Collaborators: Shanghai East Hospital
Conditions Recurrent Platinum-resistant Epithelial Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Cervical Cancers, Small Cell Lung Cancer, Hepatocellular Carcinoma (HCC), Colorectal Cancer, Non-Squamous Non-Small Cell Lung Cancer
Enrollment 120 participants
Start Date 2024-12
Primary Completion 2026-08 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2024-12-09