NCT07529535

A First-in-Human Study of ALK-N001 for Injection in Patients With Advanced Solid Tumors

An Open-label, Multicenter, Dose-escalationStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALK-N001 for Injection in Patients With Advanced Solid Tumors

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• 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 plus rollover and cohort expansion Phase I/II clinical trial conducted in patients with advanced solid tumors, including esophageal squamous cell carcinoma, small cell lung cancer, and gastric/gastroesophageal junction adenocarcinoma. It aims to evaluate the tolerability, safety, pharmacokinetics, and efficacy of ALK-N001 for injection as monotherapy in the treatment of advanced solid tumors such as esophageal squamous cell carcinoma, small cell lung cancer, and gastric/gastroesophageal junction adenocarcinoma.

Conditions

• Advance Solid Tumors

Interventions

Type	Name	Description
DRUG	ALK-N001 for Injection	The drug is administered via intravenous infusion at a constant rate . 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: 2025-06-05
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2026-04-14
• Last updated: 2026-04-17

Locations

2 sites across 1 country: China