Ignite Creation Date:
2024-05-06 @ 4:12 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04908813
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2021-05-21
Brief Title:
Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer
Sponsor:
Shanghai Henlius Biotech
Organization:
Shanghai Henlius Biotech
Study Overview
Official Title:
A Randomized Double-blindedMulticenterPhase II Clinical Study of HLX22 Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection in Combination With Trastuzumab and Chemotherapy XELOX Versus Placebo in Combination With Trastuzumab and Chemotherapy XELOX for Treatment of Locally Advanced or Metastatic Gastric Cancer GC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
The purpose of this study is to evaluate the clinical efficacy and safety of HLX22 in the HER2 Locally Adanved or Metastatic Gastric Cancer as the first-line therapyThis study consists of three periods screening period 28 days treatment period and follow-up period including safety follow-up survival follow-upSubjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria The enrolled subjects will receive an intravenous infusion of HLX22placebo and SOCstandard of care Trastuzumab XELOX once every 3 weeks until the loss of clinical benefit death intolerable toxicity withdrawal of informed consent or other reasons as specified in the protocolwhichever occurs earlier
Detailed Description:
HLX2225mgkg or HLX2215mgkg or placebo will be administered intravenously IV on day 1 of each 3-week cycle Trastuzumab 8 mgkg loading dose 6 mgkg maintenance dose will be administered IV on day 1 of each 3-week cycle SOC chemotherapy is XELOX 1000 mgm2 capecitabine administered orally twice daily BID on days 1-14 of each 3-week cycle and 130 mgm2 oxaliplatin administered IV on Day 1 of each 3-week cycle
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?:
None