Safety and Efficacy of IBI389 Single Agent, and in Combination With Sintilimab, in Patients With Advanced Malignancies

Summary

This study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of IBI389 as a single agent, and in combination with sintilimab, and (or) chemotherapy in patients with advanced or metastatic solid tumors.

Timeline

Start

2022-03-22

Primary completion

2024-04-30

Completion

2024-09-30

Publications

• Li X, Dai R, Xu Q, Guo Z, Hu C, Sun Y, Niu Z, Hao J, Zhang M, Dai G, Hua D, Pan Y, Wang X, Wei S, Chen X, Wu Q, Zhang Y, Zhou H, Ying J, Zheng L, Bi F. Safety and preliminary efficacy results of IBI389, an anti-Claudin18.2xCD3 bispecific antibody, in patients with solid tumors and gastric or gastro-esophageal tumors: a phase 1 dose escalation and expansion study. BMC Med. 2026 Jan 16;24(1):91. doi: 10.1186/s12916-025-04597-8.

Drugs

Indications