Advanced Solid TumorsPhase 1NCT07285395
AT1019 Plus SBRT and PD-1 Inhibitor for Advanced Solid Tumors: An IIT Study
A Phase 1 study testing AT1019 in people with Advanced Solid Tumors, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- AT1019
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2025to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged ≥ 18 years.
- Signed the informed consent form and have the psychological capacity to understand it.
- 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.
- Patients' disease must be evaluated according to RECIST v.1.1.
- Presence of metastatic lesions amenable to radiation therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1.
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- No evidence of clinically significant conduction abnormalities or active ischemia on electrocardiogram (ECG), as judged by the investigator.
- Acceptable organ and bone marrow function as demonstrated by the following criteria:
- Absolute neutrophil count > 1500 cells/μL; (2) Platelet count > 50,000 cells/μL; (3) Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); (4) Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 times the ULN; if hepatic metastasis exists, AST/ALT < 5 times the ULN; (5) Serum creatinine < 1.5 mg/dL and creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault formula; (6) Prothrombin time (PT)/partial thromboplastin time (PTT) ≤ 1.5 times the ULN.
- 9. Females of childbearing potential (defined as those who have experienced menarche and have not undergone successful surgical sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or are not postmenopausal (defined as at least 12 months of amenorrhea with appropriate clinical documentation, such as age > 45 years)) must undergo a serum pregnancy test prior to the first administration of study treatment and confirm a negative result.
- 10. Male and female patients of childbearing potential must agree to use two effective contraceptive methods throughout the study period.
Who cannot join
- Previous therapeutic radiotherapy to the same lesion.
- Failure to recover to grade 1 or lower from clinically significant adverse events related to prior anticancer therapy, as judged by the investigator.
- Previous grade 4 toxicity attributed to immunotherapy.
- Known untreated brain metastases or treated but unstabilized brain metastases (central nervous system lesions shown on scan to be non-progressive and not requiring corticosteroid use) ≥ 4 weeks prior to enrollment.
- QT/QTc interval prolongation (QTc interval > 470 milliseconds).
- Uncontrolled intercurrent illnesses (including but not limited to ongoing or active infections, symptomatic congestive heart failure, unstable angina, arrhythmias, or psychiatric/social conditions) that, in the investigator's judgment, would limit the patient's compliance with study requirements.
- Pregnant or lactating women.
- The Sponsor reserves the right to exclude any patient based on pre-study medical history, physical examination findings, clinical laboratory results, prior medications, or other enrollment criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Hui Qiu, M.D., Ph.D., +86 051683355832, qiuhui2015@yeah.net
About this study
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
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?
Read more
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
- Being tested
- AT1019
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT1019Drug
Also called PD-1 inhibitor, SBRT
- First receive PD-1 inhibitor treatment.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| AT1019+SBRT+PD-1 inhibitor | Experimental | Not described Receives: Drug: AT1019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Determine the DLT of AT1019 in the combination therapy of SBRT and PD-1 inhibitor.
Measured: Four weeks after the end of the combination therapy.
Maximum tolerated dose (MTD)
Determine the MTD of AT1019 in the combination therapy of SBRT and PD-1 inhibitor.
Measured: Four weeks after the end of the combination therapy.
Adverse event (AE)
Rates and severity of AEs assessed by CTCAE v5.0 criterion.
Measured: From the first dose to 12 months after the last dose.
Secondary outcomes (4)
Abscopal effect rate
The proportion of patients with an abscopal response assessed by RECIST v1.1 criterion.
Measured: 3 months after the end of the combination therapy.
Objective response rate (ORR)
To evaluate ORR of AT1019 in combination with SBRT and PD-1 inhibitor based on RECIST v1.1 criterion.
Measured: Six weeks (with a tolerance of ±1 week) after the end of the combination therapy.
Disease control rate (DCR)
To evaluate DCR of AT1019 in combination with SBRT and PD-1 inhibitor based on RECIST v1.1 criterion.
Measured: Six weeks (with a tolerance of ±1 week) after the end of the combination therapy.
Progress-free survival (PFS)
To evaluate PFS of AT1019 in combination with SBRT and PD-1 inhibitor. PFS was defined from date of recruit to date of first documentation of progression or death due to any cause.
Measured: 5 years after the end of the combination therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start12 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285395
- Sponsor's protocol ID
- AT1019-01
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07285395
- Acronym / sponsor ID
- AT1019-01
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AT1019+SBRT+PD-1 inhibitor | Experimental | Drug: AT1019 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients aged ≥ 18 years.
- Signed the informed consent form and have the psychological capacity to understand it.
- 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.
- Patients' disease must be evaluated according to RECIST v.1.1.
- Presence of metastatic lesions amenable to radiation therapy.
Key exclusion criteria (8 listed)
- Previous therapeutic radiotherapy to the same lesion.
- Failure to recover to grade 1 or lower from clinically significant adverse events related to prior anticancer therapy, as judged by the investigator.
- Previous grade 4 toxicity attributed to immunotherapy.
- Known untreated brain metastases or treated but unstabilized brain metastases (central nervous system lesions shown on scan to be non-progressive and not requiring corticosteroid use) ≥ 4 weeks prior to enrollment.
- QT/QTc interval prolongation (QTc interval > 470 milliseconds).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AT1019Also: PD-1 inhibitor, SBRT1. 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. | Drug | AT1019+SBRT+PD-1 inhibitor |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Four weeks after the end of the combination therapy.
Determine the DLT of AT1019 in the combination therapy of SBRT and PD-1 inhibitor.
Maximum tolerated dose (MTD)
Time frame: Four weeks after the end of the combination therapy.
Determine the MTD of AT1019 in the combination therapy of SBRT and PD-1 inhibitor.
Adverse event (AE)
Time frame: From the first dose to 12 months after the last dose.
Rates and severity of AEs assessed by CTCAE v5.0 criterion.
4 secondary outcomes
Abscopal effect rate
Time frame: 3 months after the end of the combination therapy.
Objective response rate (ORR)
Time frame: Six weeks (with a tolerance of ±1 week) after the end of the combination therapy.
Disease control rate (DCR)
Time frame: Six weeks (with a tolerance of ±1 week) after the end of the combination therapy.
Progress-free survival (PFS)
Time frame: 5 years after the end of the combination therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AT1019 in people with Advanced Solid Tumors, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Qiu, M.D., Ph.D. (+86 0516 83355832, qiuhui2015@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Four weeks after the end of the combination therapy.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.