drugset / Trial / NCT07529535
A First-in-Human Study of ALK-N001 for Injection in Patients With Advanced Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-06-05
- Primary completion
- 2026-12
- Completion
- 2026-12
Outcome
Outcome not reported
Stopped (Enrollment): “Participant recruitment has been stopped because the planned sample size has been reached.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALK-N001 | Unknown | 7.5 mg/m2 | Intravenous |
| Subject | ALK-N001 | Unknown | 15 mg/m2 | Intravenous |
| Subject | ALK-N001 | Unknown | 25 mg/m2 | Intravenous |
| Subject | ALK-N001 | Unknown | 37.5 mg/m2 | Intravenous |
| Subject | ALK-N001 | Unknown | 50 mg/m2 | Intravenous |
| Subject | ALK-N001 | Unknown | 62.5 mg/m2 | Intravenous |
Indications
No indication recorded.