Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-01-05 @ 5:56 PM
Study NCT ID:
NCT05360368
Status:
UNKNOWN
Last Update Posted:
2022-05-05
First Post:
2022-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HLX07(Anti-EGFR mAb) in Patients With Advanced or Metastatic Solid Tumors
Sponsor:
Shanghai Henlius Biotech
Organization:
Study Overview
Official Title:
A Phase I Clinical Study To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Patients With Advanced or Metastatic Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
NOT_YET_RECRUITING
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 Phase1, open-label and dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX07 administered as a single-agent by IV infusion every 3 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available.
Detailed Description:
None
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?: