Trials / Completed
CompletedNCT03261011
Study of the Safety, Pharmacokinetics, and Antitumor Activity of AK104 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 AK104 in Subjects With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 119 (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 AK104 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 AK104 as a single agent, and a dose expansion phase (Phase 1b) which will characterize treatment of AK104 as a single agent at the MTD or RP2D.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AK-104 | Subjects will receive AK104 by intravenous administration. |
Timeline
- Start date
- 2017-10-03
- Primary completion
- 2021-08-27
- Completion
- 2023-04-13
- First posted
- 2017-08-24
- Last updated
- 2025-02-28
Locations
6 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT03261011. Inclusion in this directory is not an endorsement.