Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487624
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-24
Brief Title:
An Engineered Sirpα Fused to Anti-Pd-L1 And Tgf-β Fusion Protein HCB301 in Subjects With Selected Advanced Tumors
Sponsor:
FBD Biologics Limited
Organization:
FBD Biologics Limited
Study Overview
Official Title:
A Phase 1 Open-label Multicenter Dose-escalation Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of HCB301 in Subjects With Advanced Solid Tumors or Relapsed and Refractory cHL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 find out whether IV injection of HCB301 is an effective treatment for different types of advanced solid tumors and relapsed and refractory classical Hodgkin lymphomas and what side effects unwanted effects may occur in subjects aged 18 years old and above
Detailed Description:
This is a phase 1 open-label multicenter dose-escalation study This study is to evaluate the safety tolerability pharmacokinetics PK preliminary efficacy and identification of maximum tolerated dose MTD of HCB301 intravenous injection in adults with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas
Eligible subjects must have failed standard therapies been intolerable or been considered medically inappropriate by the investigator Subjects will be treated until unacceptable AEs radiographic or clinical documented disease progression withdrawal of consent loss to follow-up death or termination of the study whichever occurs first
Eligible subjects must have failed standard therapies been intolerable or been considered medically inappropriate by the investigator Subjects will be treated until unacceptable AEs radiographic or clinical documented disease progression withdrawal of consent loss to follow-up death or termination of the study whichever occurs first
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