A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK127 in Combination With AK104 in Advanced and Metastatic Solid Tumours
NCT05021120 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 67
Last updated 2025-12-04
Summary
A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK127 in combination with AK104.
Conditions
- Advanced or Metastatic Solid Tumours
Interventions
- 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
Sponsors & Collaborators
-
Akesobio Australia Pty Ltd
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-12
- Primary Completion
- 2024-10-01
- Completion
- 2025-04-01
Countries
- Australia
Study Locations
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