Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-28 @ 10:56 PM
Study NCT ID:
NCT03916094
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2019-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate Safety, Tolerability and Pharmacokinetics of HLX22 in Patients With Advanced Solid Tumors Overexpressing HER2
Sponsor:
Shanghai Henlius Biotech
Organization:
Study Overview
Official Title:
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of HLX22 Monoclonal Antibody Injection (HER2 Monoclonal Antibody) in Patients With Advanced Solid Tumours Overexpressing HER2
Status:
COMPLETED
Status Verified Date:
2022-04
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:
a single-center, open-label, dose-escalation Phase I clinical trial to evaluate the safety and the tolerability of HLX22 in patients with advanced solid tumors overexpressing HER2 after failure of standard of care.
Detailed Description:
This study is an open-label and dose escalation study aimed at exploring the safety and MTD of HLX22.
three dose levels are designed for HLX22 in this study: 3, 10, and 25 mg/kg/3 weeks. The 3 mg/kg/3 weeks will serve as the starting dose. The study will use a 3+3 design to assign doses to the patients, and thereby determine the MTD of HLX22.
three dose levels are designed for HLX22 in this study: 3, 10, and 25 mg/kg/3 weeks. The 3 mg/kg/3 weeks will serve as the starting dose. The study will use a 3+3 design to assign doses to the patients, and thereby determine the MTD of HLX22.
Study Oversight
Has Oversight DMC:
False
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?: