Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-29 @ 4:44 PM
Study NCT ID:
NCT07106892
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Colorectal Cancer
Sponsor:
Shanghai Henlius Biotech
Organization:
Study Overview
Official Title:
Phase II, Open-label, Multicenter Clinical Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Colorectal Cancer
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:
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Advanced Colorectal Cancer (CRC)
Detailed Description:
This study is an open-label phase II clinical study to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with advanced Colorectal Cancer (CRC).In this study, eligible subjects will be randomized at 1:1:1 ratio, and the patients will be administered with HLX43 at different doses via intravenous infusion. After approximately 5 subjects are enrolled in each dose group, enrollment will be suspended. As soon as the efficacy signals and safety data are observed, two dose groups were selected for further exploration in Patients with advanced Colorectal Cancer (CRC).
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?: