NCT03352531

Study of the Safety, Pharmacokinetics, and Antitumor Activity of AK105 in Subjects With 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 AK105 in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 99 (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 AK105 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 AK105 as a single agent, and a dose expansion phase (Phase 1b) in subjects with specific tumor types which will characterize treatment of AK105 as a single agent at the MTD or RP2D.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
BIOLOGICAL	AK-105	Anti-PD-1 monoclonal antibody; Subjects will receive AK105 by intravenous administration.

Timeline

• Start date: 2018-01-02
• Primary completion: 2020-11-30
• Completion: 2023-10-28
• First posted: 2017-11-24
• Last updated: 2025-02-28

Locations

5 sites across 1 country: Australia