Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-31 @ 11:25 AM
Study NCT ID:
NCT05078593
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2021-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HLX26 Monoclonal Antibody Injection in Patients With Solid Tumor or Lymphoma
Sponsor:
Shanghai Henlius Biotech
Organization:
Study Overview
Official Title:
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HLX26 Monoclonal Antibody Injection (Anti LAG-3 Monoclonal Antibody) in Patients With Advanced/Metastatic Solid Tumor or Lymphoma
Status:
COMPLETED
Status Verified Date:
2023-09
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 a first-in-class open-label phase I human clinical study to evaluate the safety and tolerability of HLX26 with escalated doses in the treatment of patients with advanced/metastatic solid tumors or lymphomas.
Detailed Description:
This study is a first-in-class open-label phase I human clinical study to evaluate the safety and tolerability of HLX26 with escalated doses in the treatment of patients with advanced/metastatic solid tumors or lymphomas. In this study, accelerated titration is combined with a 3 + 3 dose escalation method, and the patients will be given different doses(60mg, 150mg, 300mg, 500mg, 800mg Q3W) of HLX26 intravenously. Observation period of DLT lasts for 3 weeks after the first administration of HLX26.
Study Oversight
Has Oversight DMC:
True
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?: