Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 4:48 AM
Study NCT ID:
NCT07416695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 in Patients With Advanced SCLC or NEC
Sponsor:
Shanghai Henlius Biotech
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: