Actively Recruiting
AT1019 Plus SBRT and PD-1 Inhibitor for Advanced Solid Tumors: An IIT Study
Led by The Affiliated Hospital of Xuzhou Medical University · Updated on 2025-12-16
12
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
AT1019 Plus SBRT and PD-1 Inhibitor for Advanced Solid Tumors: An IIT Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older
- Signed informed consent and able to understand it
- Diagnosed with advanced solid malignant tumors receiving immunotherapy and planned for SBRT
- Achieved at least stable disease during previous immunotherapy
- Disease evaluated by RECIST v.1.1 criteria
- Presence of metastatic lesions suitable for radiation therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- No clinically significant conduction problems or active ischemia on ECG
- Acceptable organ and bone marrow function as defined by specified blood counts and liver/kidney function tests
- Females of childbearing potential must have a negative pregnancy test before treatment
- Patients of childbearing potential must agree to use two effective contraceptive methods during the study period
You will not qualify if you...
- Previous radiotherapy to the same lesion
- Not recovered to grade 1 or lower from adverse events related to prior cancer therapy
- Previous grade 4 toxicity from immunotherapy
- Untreated or unstable brain metastases within 4 weeks before enrollment
- QTc interval longer than 470 milliseconds
- Uncontrolled illnesses such as infections, heart failure, unstable angina, arrhythmias, or psychiatric/social conditions
- Pregnant or breastfeeding women
- Other exclusions based on medical history, physical exam, lab results, or prior medications as judged by the sponsor
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
Actively Recruiting
Research Team
H
Hui Qiu, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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