Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04797468
Status:
WITHDRAWN
Last Update Posted:
2023-01-17
First Post:
2021-03-04
Brief Title:
A Phase 1 Study of the CD73 InhibitorHLX23 Alone in Participants With Solid Tumor
Sponsor:
Shanghai Henlius Biotech
Organization:
Shanghai Henlius Biotech
Study Overview
Official Title:
A Phase 1 Clinical Study to Investigate the Safety Tolerability and to Determine the Maximum Tolerated Dose and Recommended Phase 2 Dose of HLX23 CD73 Inhibitor in Patients With Advanced or Metastatic Solid Tumors
Status:
WITHDRAWN
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The Early Termination is the result of the sponsors need to reevaluate the study design and to make needed vendor realignments
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The reason for this study is to see if the CD73 inhibitor HLX23 alone is safe and effective in participants with advanced solid cancer
Detailed Description:
An open-label dose escalation first-in-human phase 1 clinical study to investigate the safety tolerability and to determine the maximum tolerated dose and recommended phase 2 dose of HLX23 recombinant anti-CD73 humanized monoclonal antibody in patients with advanced or metastatic solid tumors
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?:
None