Health Trials

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

ConditionsRecurrent Platinum-resistant Epithelial Ovarian CancerTriple Negative Breast Cancer (TNBC)Cervical CancersSmall Cell Lung CancerHepatocellular Carcinoma (HCC)Colorectal CancerNon-Squamous Non-Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTasly Biopharmaceuticals Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Voluntary participation in the study and provision of signed and dated informed consent;

Age ≥ 18 years at the time of informed consent;

Recurrent platinum-resistant epithelial ovarian cancer (including primary peritoneal and/or fallopian tube cancer): pathologically confirmed ovarian epithelial malignancy, fallopian tube epithelial malignancy, primary peritoneal cancer; and diagnosed platinum-resistant (duration of response to platinum-based therapy is within 6 months after the last dose of platinum-based therapy)

Triple-negative breast cancer: pathologically confirmed unresectable locally advanced or metastatic breast cancer with negative ER, PR, and HER-2. ER, PR negativity was defined as: IHC ER < 1%, IHC PR < 1%. HER-2 negativity is defined as IHC HER-2 (-) or (1 +), and FISH must be performed and the result is negative for HER-2 (2 +) ③ Cervical cancer: pathologically confirmed inoperable locally advanced or metastatic cervical cancer

Disqualifiers

Prior use of anti-PD-1 monoclonal antibody, anti-PD-L1 monoclonal antibody, or other antineoplastic agents containing PD- (L) 1 target;

Patients who have previously used macromolecular VEGF/VEGFR inhibitors such as bevacizumab, ramucirumab;

Known hypersensitivity to the study drug or any of its components, or previous severe hypersensitivity to macromolecular protein preparations/monoclonal antibodies or bispecific antibodies;

Female patients are pregnant or lactating;

Trial design

Treatments tested in this trial

  • B1962

Treatment groups

120 Participants
are divided into 1 treatment group

Sponsors and collaborators

Tasly Biopharmaceuticals Co., Ltd.

Lead sponsor

Shanghai East Hospital

Collaborator

Source ClinicalTrials.gov