Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2025-12-31 @ 10:49 PM
Study NCT ID:
NCT04987112
Status:
RECRUITING
Last Update Posted:
2023-12-22
First Post:
2021-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors
Sponsor:
CanWell Pharma Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Dose Escalation, Open-Label Study of Intratumoral CAN1012 in Subjects With Unresectable or Metastatic Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-12
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:
To evaluate CAN1012(Selective TLR7 agonist) when administered by IT injection to subjects with advanced solid tumors who are not candidates for standard therapy.
Detailed Description:
This is a Phase 1, open-label, first-in-human, single-arm, multicenter, dose escalation study of IT CAN1012 in subjects with advanced solid tumors who are not candidates for standard therapy.
Subjects will be enrolled in cohorts of 3 at each dose level using a 3+3 dose escalation design Approach.
Subjects will be enrolled in cohorts of 3 at each dose level using a 3+3 dose escalation design Approach.
Study Oversight
Has Oversight DMC:
False
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?: