AT1019 Plus SBRT and PD-1 Inhibitor for Advanced Solid Tumors: An IIT Study
Trial Parameters
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.
Eligibility Criteria
Inclusion Criteria: 1. Male or female patients aged ≥ 18 years. 2. Signed the informed consent form and have the psychological capacity to understand it. 3. Patients with advanced solid malignant tumors (such as non-small cell lung cancer, renal cell carcinoma, head and neck cancer, cervical cancer, and urothelial carcinoma) who are receiving immunotherapy and planned to undergo SBRT. Patients are eligible if they achieved at least stable disease during previous immunotherapy. 4. Patients' disease must be evaluated according to RECIST v.1.1. 5. Presence of metastatic lesions amenable to radiation therapy. 6. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1. 7. No evidence of clinically significant conduction abnormalities or active ischemia on electrocardiogram (ECG), as judged by the investigator. 8. Acceptable organ and bone marrow function as demonstrated by the following criteria: (1) Absolute neutrophil count \> 1500 cells/μL; (2) Platelet count \> 50,000 cel