Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341647
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-14
Brief Title:
Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201
Sponsor:
GC Cell Corporation
Organization:
GC Cell Corporation
Study Overview
Official Title:
A Multicenter Open-label Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced Human Epidermal Growth Factor Receptor 2 PositiveHER2 Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
This clinical trial will enroll subjects with HER2 solid tumors and is conducted in two phases which are phase 1a and phase 1b The primary objective of phase 1 is to determine the safety and tolerability of AB-201 in subjects with advanced HER2 solid tumors
Detailed Description:
This is a Phase 1 multicenter study designed to evaluate the safety tolerability and efficacy of AB-201 in subjects with advanced HER2 solid tumors specifically breast and gastricGEJ cancers
The Phase 1 will be conducted in two parts an initial dose escalation stage followed by a dose expansion stage
Study participation for each subject begins with up to 28 days 1 month of screening following written informed consent then lymphodepletion treatment followed by AB-201 Up to 3 doses of AB-201 may be administered All subjects will be monitored for a total duration of 18 months of follow up from the first dose administration of AB-201
The Phase 1 will be conducted in two parts an initial dose escalation stage followed by a dose expansion stage
Study participation for each subject begins with up to 28 days 1 month of screening following written informed consent then lymphodepletion treatment followed by AB-201 Up to 3 doses of AB-201 may be administered All subjects will be monitored for a total duration of 18 months of follow up from the first dose administration of AB-201
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 103300 HREC 23323 | OTHER | TGA Australia | None |