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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

NCT06724263 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-12-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

B1962

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

Sponsors & Collaborators

  • Shanghai East Hospital

    collaborator OTHER

  • Tasly Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06724263 on ClinicalTrials.gov