Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-01 @ 1:39 PM
Study NCT ID:
NCT05274204
Status:
TEMPORARILY_NOT_AVAILABLE
Last Update Posted:
2023-02-27
First Post:
2022-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individual Patient Expanded Access to CA102N
Sponsor:
Holy Stone Healthcare Co., Ltd
Organization:
Study Overview
Official Title:
Expanded Access to CA102N in One Patient Who Completed at Least 12 Cycles of Combination Therapy of CA102N Plus Lonsurf in Clinical Study Number of HS-CA102N-101
Status:
TEMPORARILY_NOT_AVAILABLE
Status Verified Date:
2023-02
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 study is an individual patient expanded access protocol that the subject enrolled had completed the combination treatment of CA102N plus Lonsurf for at least 12 cycles.
Detailed Description:
In the individual patient expanded access, the subject who was enrolled in Phase 1 trial (Study Number: HS-CA102N-101) Part 2 (dose expansion) and had completed at least 12 treatment cycles with CA102N combined with trifluridine /tipiracil (LONSURF) will be provided access to treatment with CA102N (0.72 mg/kg Nimesulide Equivalent of CA102N).
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: