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NOT YET RECRUITING
NCT07509684
PHASE1/PHASE2

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

Sponsor: Zhejiang Anglikang Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

Primary Objective: 1、 evaluate the preliminary efficacy of ALK-N001 for Injection in patients with advanced solid tumors. Secondary Objectives: 1. To evaluate the safety of ALK-N001 for Injection in patients with advanced solid tumors. 2. To further evaluate the population pharmacokinetic (PPK) profile of ALK-N001 for Injection in targeted patients with advanced solid tumors. Exploratory Objectives: 1. To investigate the expression of Legumain in tumor tissues and evaluate the correlation between Legumain expression and efficacy. 2. To identify metabolites of ALK-N001 for Injection in blood (if applicable).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

190

Start Date

2026-04

Completion Date

2029-06

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

DRUG

ALK-N001 for Injection

The investigational product was ALK-N001 for Injection (10 mg/vial), supplied as a white to pale yellow lyophilized cake or powder. It is reconstituted and diluted with normal saline (0.9% Sodium Chloride Injection) or 5% glucose injection prior to administration. The drug is administered via intravenous infusion at a constant rate over 2 hours ± 20 minutes. The study employed a sequential dose-escalation design, beginning with a dose of 62.5 mg/m². 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.