NCT07416695

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

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 (DLL3 × DLL3 × CD3 × CD28 Tetra-specific Antibody) in Patients With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

phase Ia is the dose escalation and backfill stage, accelerated titration and 3 + 3 dose escalation method will be adopted in the dose escalation stag, and the patients will be administered with HLX3901 at different doses via intravenous infusion. The DLT observation period lasts for 4 weeks after the first administration of HLX3901. The backfill cohort will enrolls 2 to 3 dose groups. Part Ib is a dose-expansion study of HLX3901, designed to explore and confirm the efficacy and safety of HLX3901 monotherapy in advanced small-cell lung cancer or neuroendocrine carcinoma.The Safety Review Committee will recommend dose groups for expansion based on the safety, efficacy and PK data of the dose escalation phase.

Conditions

• SCLC
• NEC

Interventions

Type	Name	Description
DRUG	HLX3901	• HLX3901 will be administered as an intravenous (IV) infusion.

Timeline

• Start date: 2026-04-30
• Primary completion: 2028-05-30
• Completion: 2029-06-30
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: China