Clinical Trial

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

Recruiting Phase 1
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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.
Trial Details
NCT Number NCT07285395
Lead Sponsor The Affiliated Hospital of Xuzhou Medical University
Conditions Advanced Solid Tumors
Enrollment 12 participants
Start Date 2025-11-12
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-16