Clinical Trial

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 in Patients With Advanced SCLC or NEC

Recruiting Phase 1
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Summary
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX3901 in patients with Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-04-30
critical Primary endpoint(s) modified 2026-04-30
Trial Details
NCT Number NCT07416695
Lead Sponsor Shanghai Henlius Biotech
Conditions SCLC, NEC
Enrollment 138 participants
Start Date 2026-04-17
Primary Completion 2028-05-30 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-08