NCT04597541

A Study of AK112 for Advanced Solid Tumors

A Phase I/II Trial of AK112 in Advanced Solid Tumor

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	AK112	AK112 is a PD1/VEGF bispecific antibody;AK112 is given by intravenous infusion.

Timeline

• Start date: 2020-10-21
• Primary completion: 2022-03-31
• Completion: 2024-07-15
• First posted: 2020-10-22
• Last updated: 2025-03-10

Locations

1 site across 1 country: China