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RECRUITING
NCT06707610
PHASE1

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

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