Ignite Creation Date:
2025-12-24 @ 1:15 PM
Ignite Modification Date:
2025-12-28 @ 11:12 PM
Study NCT ID:
NCT07285395
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AT1019 Plus SBRT and PD-1 Inhibitor for Advanced Solid Tumors: An IIT Study
Sponsor:
The Affiliated Hospital of Xuzhou Medical University
Organization:
Study Overview
Official Title:
A Phase I Investigator-Initiated Trial (IIT) of AT1019 Combined With Stereotactic Body Radiation Therapy (SBRT) and PD-1 Inhibitor for Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-12
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:
The goal of this clinical trial is to assess the safety and tolerability of AT1019 when used in combination with SBRT and PD-1 inhibitor, and determine the maximum tolerated dose (MTD) of AT1019 in the combination therapy of SBRT and PD-1 inhibitor in patients with advanced solid tumors. The main questions it aims to answer are:
Is the combination of AT1019, SBRT and PD-1 inhibitor safe and well-tolerated in patients with advanced solid tumors? What is the maximum tolerated dose (MTD) of AT1019 when combined with SBRT and PD-1 targeted immunotherapy?
Participants will:
* First receive PD-1 inhibitor treatment as scheduled.
* Undergo SBRT, which will be given in 3 to 5 fractions, with each fraction ranging from 6Gy to 18Gy, and the treatment will be administered once a week.
* Receive intratumoral injection of AT1019 within 1 to 2 days after each SBRT session.
* Undergo imaging examinations every 6 weeks (with a tolerance of ±1 week) to evaluate the treatment effect.
Is the combination of AT1019, SBRT and PD-1 inhibitor safe and well-tolerated in patients with advanced solid tumors? What is the maximum tolerated dose (MTD) of AT1019 when combined with SBRT and PD-1 targeted immunotherapy?
Participants will:
* First receive PD-1 inhibitor treatment as scheduled.
* Undergo SBRT, which will be given in 3 to 5 fractions, with each fraction ranging from 6Gy to 18Gy, and the treatment will be administered once a week.
* Receive intratumoral injection of AT1019 within 1 to 2 days after each SBRT session.
* Undergo imaging examinations every 6 weeks (with a tolerance of ±1 week) to evaluate the treatment effect.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: