NCT07285395

AT1019 Plus SBRT and PD-1 Inhibitor for Advanced Solid Tumors: An IIT Study

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: The Affiliated Hospital of Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	AT1019	1. First receive PD-1 inhibitor treatment. 2. 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. 3. Receive intratumoral injection of AT1019 within 1 to 2 days after each SBRT session.

Timeline

• Start date: 2025-11-12
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-12-16
• Last updated: 2025-12-16

Locations

1 site across 1 country: China