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

Sponsor
Tasly Biopharmaceuticals Co., Ltd.
Study ID
NCT06724263
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cervical Cancers
  • Colorectal Cancer
  • Hepatocellular Carcinoma (HCC)
  • Non-Squamous Non-Small Cell Lung Cancer
  • Recurrent Platinum-resistant Epithelial Ovarian Cancer
  • Small Cell Lung Cancer
  • Triple Negative Breast Cancer (TNBC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • B1962 — DRUG
    B1962 has higher VEGF anti angiogenic activity than its competitors. Phase I clinical trials have shown that B1962 has excellent safety and promising therapeutic effects. Large scale clinical studies may achieve better therapeutic effects than similar competitors targeting the same target

Study Details

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.

Key Dates

First listed
Dec 9, 2024
Start date
Dec 31, 2024
Status verified
Dec 2024
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: B1962
    advanced malignant neoplasm

Primary Outcome Measure

ORR [ Time Frame: 24 months ]

Central Contacts

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