Clinical Trial

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors

Recruiting Phase 1/2
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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.
Protocol Amendment History 1 change
notable Trial sites expanded: 2 -> 38 locations 2026-05-23
Trial Details
NCT Number NCT06656390
Lead Sponsor Shanghai Allink Biotherapeutics Co., Ltd.
Conditions Advanced Cancer, Advanced Solid Tumors
Enrollment 202 participants
Start Date 2024-10-24
Primary Completion 2027-10-22 (estimated)
Study Completion 2028-04-22 (estimated)
Updated on ClinicalTrials.gov 2026-05-22