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

NCT07509684 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2026-04-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Zhejiang Anglikang Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-12-31
Completion
2029-06-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07509684 on ClinicalTrials.gov