Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636435
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
A Phase I First in Human Study of CBA-1205 Anti-DLK1 Monoclonal Antibody in Patients with Advanced Solid Tumors and Hepatocellular Carcinoma HCC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I First in Human Study of CBA-1205 Anti-DLK1 Monoclonal Antibody in Patients with Advanced Solid Tumors and Hepatocellular Carcinoma HCC
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this first-in-human multicenternon-randomized open-label standard 33 dose escalation Phase I study encompasses 3partsPart1-3 The purpose of this FIH study is to evaluate the safety and tolerability profile of CBA-1205
Detailed Description:
To evaluate safety and efficacy of CBA-1205 in the following three parts in a stepwise manner
In Part 1 safety and tolerability in patients with solid tumor where no standard treatment is available or who are intolerable or non-responder to the standard treatment will be evaluated Initial dose for Part 2 will be determined
In Part 2 safety and tolerability in patients with advanced andor recurrent hepatocellular carcinoma which are unresectable or who are intolerable or non-responder to the standard treatment will be evaluated Recommended dose in this population will be determined
In Part 3 safety and efficacy at the recommended dose in patients with advanced andor recurrent hepatocellular carcinoma which are unresectable or who are intolerable or non-responder to the standard treatment will be evaluated
PK analysis
In Part 1 safety and tolerability in patients with solid tumor where no standard treatment is available or who are intolerable or non-responder to the standard treatment will be evaluated Initial dose for Part 2 will be determined
In Part 2 safety and tolerability in patients with advanced andor recurrent hepatocellular carcinoma which are unresectable or who are intolerable or non-responder to the standard treatment will be evaluated Recommended dose in this population will be determined
In Part 3 safety and efficacy at the recommended dose in patients with advanced andor recurrent hepatocellular carcinoma which are unresectable or who are intolerable or non-responder to the standard treatment will be evaluated
PK analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None