drugset
drugset / Trial / NCT05650385

A Study of B1962, a PD-L1/VEGF Bispecific Antibody Fusion Protein, for Advanced Solid Tumors

NCT05650385 ↗

Phase 1 Unknown 68 enrolled Tasly Biopharmaceuticals Co., Ltd.
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2022-12
Primary completion
2023-12
Completion
2025-10

Drugs

EvaluationDrugModalityDoseRoute
Subject B1962 Protein / enzyme biologic 0.035 mg —
Subject B1962 Protein / enzyme biologic 0.12 mg —
Subject B1962 Protein / enzyme biologic 0.4 mg —
Subject B1962 Protein / enzyme biologic 1.2 mg —
Subject B1962 Protein / enzyme biologic 4 mg —
Subject B1962 Protein / enzyme biologic 8 mg —
Subject B1962 Protein / enzyme biologic 11 mg —
Subject B1962 Protein / enzyme biologic 15 mg —
Subject B1962 Protein / enzyme biologic 20 mg —
Subject B1962 Protein / enzyme biologic 25 mg —

Indications

cancer