NCT05650385

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

A Multicenter, Open-label, Dose-escalating Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of B1962 Injection in the Treatment of Advanced Malignant Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Tasly Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	B1962	B1962 is a PD-L1/VEGF bispecific antibody fusion protein.

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-12-01
• Completion: 2025-10-01
• First posted: 2022-12-14
• Last updated: 2022-12-14

Locations

1 site across 1 country: China