NCT06707610

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 234 (estimated)
• Sponsor: Shanghai Allink Biotherapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Cancer
• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	ALK202	Administered intravenously, once every 3 weeks

Timeline

• Start date: 2025-02-10
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2024-11-27
• Last updated: 2025-03-12

Locations

4 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study