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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors
Sponsor: Shanghai Allink Biotherapeutics Co., Ltd.
Summary
This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK201. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK201 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK201.
Official title: A First-in-Human, Open-Label, Multi-Center Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK201 for Injection in Adult Participants With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
202
Start Date
2024-10-24
Completion Date
2028-04-22
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
ALK201
Administered intravenously, once every 3 weeks
Locations (2)
Cancer Care Wollongong
Wollongong, New South Wales, Australia
Shanghai East Hospital
Shanghai, Shanghai Municipality, China