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RECRUITING
NCT07285395
PHASE1

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

Sponsor: The Affiliated Hospital of Xuzhou Medical University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2025-11-12

Completion Date

2027-12-31

Last Updated

2025-12-16

Healthy Volunteers

No

Interventions

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.

Locations (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China