NCT06092580

Phase 1 Study of AWT020 in Advanced Cancer

A Phase 1/2, First-in-human, Open-label Study of Single-agent AWT020 in Patients With Progressive Locally Advanced or Metastatic Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Anwita Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aims of this clinical trial are (1) to assess the safety of AWT020 at different dose levels; (2) to determine the pharmacokinetics and pharmacodynamics of AWT020 in subjects with locally advanced or metastatic cancer who have failed standard therapy.

Detailed description

This study will enroll subjects with locally advanced or metastatic cancer who have failed standard therapy. Subjects enrolled into this study will be assigned a dose level and receive AWT020 via intravenous infusion at a regular interval. The treatment will be continued until disease progression, withdrawal from study or death. The primary objective is to investigate the safety of this agent. The secondary objective is to investigate the pharmacokinetics, pharmacodynamic, potential anti-tumor activity and immunogenicity of this agent.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
BIOLOGICAL	AWT020	Participants receiving AWT020 once every two weeks or longer at designated dose levels

Timeline

• Start date: 2023-09-15
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2023-10-23
• Last updated: 2025-09-02

Locations

4 sites across 1 country: Australia