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RECRUITING
NCT06656390
PHASE1/PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

ALK201

Administered intravenously, once every 3 weeks

Locations (2)

Cancer Care Wollongong

Wollongong, New South Wales, Australia

Shanghai East Hospital

Shanghai, Shanghai Municipality, China