NCT04047290

A Study of AK112, a PD-1/VEGF Bispecific Antibody, for Advanced Solid Tumors

A Phase 1a/1b, Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK112 in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Akesobio Australia Pty Ltd · Industry
• Sex: All
• Age: 18 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. The study consists of a dose escalation phase (Phase 1a) to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for AK112 as a single agent, and a dose expansion phase (Phase 1b) in subjects with specific tumor types which will characterize treatment of AK112 as a single agent at the MTD or RP2D.

Conditions

• Neoplasms Malignant

Interventions

Type	Name	Description
DRUG	AK112	AK112 is a PD1/VEGF bispecific antibody.

Timeline

• Start date: 2019-09-20
• Primary completion: 2024-02-27
• Completion: 2024-02-27
• First posted: 2019-08-06
• Last updated: 2025-02-28

Locations

7 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study