NCT06656390

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 202 (estimated)
• Sponsor: Shanghai Allink Biotherapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Cancer
• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	ALK201	Administered intravenously, once every 3 weeks

Timeline

• Start date: 2024-10-24
• Primary completion: 2027-10-22
• Completion: 2028-04-22
• First posted: 2024-10-24
• Last updated: 2026-03-06

Locations

2 sites across 2 countries: Australia, China

Regulatory

• FDA-regulated drug study