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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors
Sponsor: Shanghai Allink Biotherapeutics Co., Ltd.
Summary
TThis is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK202. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK202.
Official title: A First-in-Human, Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK202 for Injection in Adult Participants with Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
234
Start Date
2025-02-10
Completion Date
2028-12
Last Updated
2025-03-12
Healthy Volunteers
No
Conditions
Interventions
ALK202
Administered intravenously, once every 3 weeks
Locations (4)
D&H Cancer Research Center Llc
Margate, Florida, United States
Next Oncology
Fairfax, Virginia, United States
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia
Macquarie University
Sydney, New South Wales, Australia