A Study of B1962, a PD-L1/VEGF Bispecific Antibody Fusion Protein, for Advanced Solid Tumors
NCT05650385 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2022-12-14
Summary
This study is to characterize the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of B1962, a PD-L1/VEGF bispecific antibody fusion protein, as a single agent in adult subjects with advanced solid tumor malignancies. The study consists of two parts: a once-weekly (QW) dosing phase and a biweekly (Q2W) dosing phase, which will explore the possibility of Q2W dosing of B1962 based on the PK data obtained in the QW phase. The study will determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for B1962 as a single agent.
Conditions
- Neoplasms Malignant
Interventions
- DRUG
-
B1962
B1962 is a PD-L1/VEGF bispecific antibody fusion protein.
Sponsors & Collaborators
-
Tasly Biopharmaceuticals Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Kongli zhu, Master · Tasly Biopharmaceuticals Co., Ltd.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-31
- Primary Completion
- 2023-12-31
- Completion
- 2025-10-31
Countries
- China
Study Locations
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