NCT05021120

A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK127 in Combination With AK104 in Advanced and Metastatic Solid Tumours

A Phase 1a/1b, Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumour Activity of AK127 in Combination With AK104 in Subjects With Advanced or Metastatic Solid Tumours

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Akesobio Australia Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK127 in combination with AK104.

Detailed description

This is a , Phase 1, first-in-human, multicenter, open label, dose escalation and dose expansion study designed to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK127 in combination with AK104 in subjects with advanced and metastatic solid tumours. The study comprises of 2 phases: a dose escalation phase and a dose expansion phase. Dose escalation for AK127 will occur using the 3+3+3 model given with a fixed regimen of AK104. Dose expansion will open at the discretion of the Sponsor.

Conditions

• Advanced or Metastatic Solid Tumours

Interventions

Type	Name	Description
DRUG	AK127	Subjects will receive AK127 by intravenous administration
DRUG	AK104	After AK127 infusion, on the same day subjects will receive AK104 by intravenous administration

Timeline

• Start date: 2021-10-12
• Primary completion: 2024-10-01
• Completion: 2025-04-01
• First posted: 2021-08-25
• Last updated: 2025-12-04

Locations

5 sites across 1 country: Australia