Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT07160335
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors
Sponsor:
Shanghai Henlius Biotech
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® (US-sourced Keytruda®) in Multiple Resected Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-11
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 is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety, and immunogenicity of HLX17 vs. US-sourced Keytruda® in patients with resected non-small cell lung cancer (NSCLC) or melanoma (MEL), or renal cell carcinoma (RCC).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?: