NCT07509684

A Phase Ib/II Study Evaluating Injectable ALK-N001 in Patients With Advanced Solid Tumors

An Open-label, Multicenter Phase Ib/II Study Evaluating the Efficacy, Safety and Pharmacokinetics of Injectable ALK-N001 in Patients With Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Zhejiang Anglikang Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, open-label, dose-escalation and cohort-expansion Phase Ib/II clinical trial conducted in patients with advanced solid tumors, aiming to evaluate the safety, pharmacokinetics and efficacy of ALK-N001 for injection as monotherapy in the treatment of advanced solid tumors.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	ALK-N001 for Injection	The drug is administered via intravenous infusion at a constant rate over 2 hours ± 20 minutes. The primary dosing schedule was every 2 weeks (Q2W) in a 28-day cycle, while an every 3 weeks (Q3W) schedule with a 21-day cycle was also explored.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-01
• Completion: 2029-06-01
• First posted: 2026-04-03
• Last updated: 2026-04-13