A Study of AK112 for Advanced Solid Tumors

Summary

This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK112, a PD-1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumor malignancies. This trial is a two parts, phase I/II study. All patients are advanced solid tumor, Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Part one is dose escalation phase,part two is dose expansion phase. The primary end point is safety. Secondary end points are objective response rate,progression-free survival and overall survival per RECIST1.1.

Timeline

Start

2020-10-21

Primary completion

2022-03-31

Completion

2024-07-15

Publications

• Wang F, Wei X, Zheng Y, Wang J, Ying J, Chen X, Luo S, Luo H, Yu X, Chen B, Ma L, Xu R. Safety, Pharmacokinetics, and Pharmacodynamics Evaluation of Ivonescimab, a Novel Bispecific Antibody Targeting PD-1 and VEGF, in Chinese Patients With Advanced Solid Tumors. Cancer Med. 2025 Mar;14(6):e70653. doi: 10.1002/cam4.70653.

Drugs

Indications