Advanced Solid TumorPhase 1STM-06NCT07269080
STM-06: POLARIS-POlymetastic Lesion Ablative Radiotherapy With Immunotherapy Study
A Phase 1 study testing Ablative radiation treatment in people with Advanced Solid Tumor and Metastatic Cancer, run by University of Illinois Chicago at 1 site in United States.
Trial summary
This is a non-randomized two-arm trial, specifically a pilot study in which patients with advanced solid tumor cancer with 3-10 metastatic lesions who are on immunotherapy will receive ablative RT to up to 10 lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Metastatic Cancer
- What is being tested?
- Ablative radiation treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2025to Nov 2028
- 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
- Age ≥ 18 years of age at the time of consent
- ECOG (0, 1, or 2) within 30 days prior to registration.
- Subjects with advanced solid tumors with at least 3 but no more than 10 sites of metastatic disease, excluding the primary tumor.
- Disease site must be outside of the GI tract (including esophagus, stomach, small or large bowel, and mesenteric lymph nodes), brainstem, and skin.
- Demonstrates adequate organ function. All screening labs are to be obtained within 30 days prior to registration.
- Able to provide written informed consent and HIPAA authorization for release of personal health information via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization. If a subject is unable to consent, a Legally Authorized Representative (LAR) may provide consent on their behalf.
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- Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
- As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study.
- Have a life expectancy of at least 3 months.
- Subjects receiving treatment for >3 months with an FDA-approved immunotherapy agent such as a PD-1 inhibitor, a PD-L1 inhibitor, a CTLA-4 inhibitor, or an LAG-3 inhibitor; either as monotherapy or in combination with another FDA-approved immunotherapy agent. Subjects may have received prior combination cytotoxic chemotherapy and immunotherapy, but must be receiving only immunotherapy for at least 30 days prior to registration.
- Cohort A: Subjects with investigator-assessed stable disease or partial response after > 3 months of immunotherapy treatment prior to registration
- Cohort B: Subjects with oligo-progression defined as having at least 3 sites of disease during their disease course, with at least 1 but up to 5 sites of progressive disease within 3 months of registration. Subjects must have investigator-assessed stable disease, partial response, or complete response as prior best response to immunotherapy and have been on immunotherapy for at least 3 months prior to registration.
Who cannot join
- Inability to treat all sites of disease
- >10 metastatic lesions at any point in the disease course
- History of interstitial lung disease or G3 or worse pneumonitis
- Malignant pleural effusion
- Active infection requiring IV antibiotics
- Active autoimmune disease requiring immunosuppression in the last two years from enrollment.
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- Significant medical comorbidities precluding radiotherapy as determined by the treating physician.
- Use of systemic corticosteroids equivalent to prednisone ≥10 mg daily within 14 days prior to registration, or requirement for systemic corticosteroids at screening for disease control, unless used as physiologic replacement (e.g., adrenal insufficiency). Subjects who require systemic steroids ≥10 mg/day for clinical management will be ineligible.
- Substantial overlap with a previously treated radiation volume.
- For patients with liver metastases, moderate/severe liver dysfunction (Child-Pugh B or C)
- Patients with symptomatic brain metastases, a single metastasis greater than 5 cm in size, or any brain metastasis greater than 3 cm in size. Patients with total brain metastases volume exceeding 30 cc.
- Clinical or radiologic evidence of spinal cord compression.
- Metastatic disease involving the GI tract (esophagus, stomach, small or large bowel, mesenteric lymph nodes), disease in the brainstem, or skin
- Pregnant or nursing
- Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.
- Other major comorbidity, as determined by the study PI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
Ryan Nguyen, DO
About this study
This is a non-randomized two-arm trial, specifically a pilot study in which patients with advanced solid tumor cancer with 3-10 metastatic lesions who are on immunotherapy will receive ablative RT to up to 10 lesions. After study intervention, participants will undergo ctDNA collection at 8 weeks after completion of ablative RT Post-treatment disease assessments, including imaging and serial ctDNA monitoring, as well as any additional treatments, will be at the discretion of the treating oncologist. Approximately 28 subjects (14 per cohort) will be enrolled. For subjects who do not complete the full planned course of RT for any reason, a final study visit should be performed approximately 30 days after the last fraction of radiation. If a subject is discontinued from the study with an ongoing adverse event or an unresolved clinically significant laboratory result, the clinical investigative team will attempt to provide follow-up until a satisfactory clinical resolution of the laboratory result or adverse event is achieved.
- Conditions
- Advanced Solid Tumor, Metastatic Cancer
- Being tested
- Ablative radiation treatment
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablative radiation treatmentRadiation
Ablative radiation for all metastases should be completed within 3 weeks of the first dose of radiation. Metastases may be treated on an everyday or every other day schedule.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Radiotherapy in Participants with Stable Disease or Partial Response | Other | Participants with investigator-assessed stable disease or partial response after > 3 months of immunotherapy treatment prior to registration Receives: Radiation: Ablative radiation treatment |
| Treatment with Radiotherapy in Patients with Oligo-progression | Other | Participants with oligo-progression defined as having at least 3 sites of disease during their disease course, with at least 1 but up to 5 sites of progressive disease within 3 months of registration. Participants must have investigator-assessed stable disease, partial response, or complete response as prior best response to immunotherapy and have been on immunotherapy for at least 3 months prior to registration. Receives: Radiation: Ablative radiation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the proportion of patients with advanced tumors and polymetastatic disease on immunotherapy who achieve a molecular response (>50% ctDNA reduction) at 8 weeks following ablative radiation therapy
Measured: Baseline to 8 weeks following the end of ablative radiation therapy
Secondary outcomes (4)
To evaluate 6-month and 12-month overall survival (OS)
Overall survival is defined as the time from the first dose to death due to any cause, incidence of serious adverse events in all groups according to CTCAE version 6.
Measured: Registration date until the off-study date, approximately 12 months after the end of radiation therapy
To evaluate 6-month and 12-month progression-free survival (PFS)
Progression-free survival is defined as the time from the time of enrollment to disease progression or death, whichever occurs first
Measured: Registration date until the off-study date, approximately 12 months after the end of radiation therapy
To evaluate overall response rate
Overall response rate is defined as partial response (PR) or complete response (CR) occurring at any point during treatment, as assessed by the treating physician
Measured: Registration date until the off-study date, approximately 12 months after the end of radiation therapy
To evaluate all grades of treatment-related adverse events (TRAEs)
Treatment related adverse events will be assessed by CTCAE version 6.
Measured: Treatment start until the off-study date, approximately 12 months after the end of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start8 Dec 2025
- Primary completionJan 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Nguyen, University of Illinois Chicago
- Investigators
- Ryan Nguyen, DO, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269080
- Sponsor's protocol ID
- 2025-0362
- Acronym
- STM-06
- Status last verified
- Feb 2026
- First submitted
- 21 Nov 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STM-06: POLARIS-POlymetastic Lesion Ablative Radiotherapy With Immunotherapy Study
- ClinicalTrials.gov ID
- NCT07269080
- Acronym / sponsor ID
- STM-06 / 2025-0362
- Conditions
- Advanced Solid Tumor, Metastatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 8 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.
This is a non-randomized two-arm trial, specifically a pilot study in which patients with advanced solid tumor cancer with 3-10 metastatic lesions who are on immunotherapy will receive ablative RT to up to 10 lesions. After study intervention, participants will undergo ctDNA collection at 8 weeks after completion of ablative RT Post-treatment disease assessments, including imaging and serial ctDNA monitoring, as well as any additional treatments, will be at the discretion of the treating oncologist. Approximately 28 subjects (14 per cohort) will be enrolled. For subjects who do not complete the full planned course of RT for any reason, a final study visit should be performed approximately 30 days after the last fraction of radiation. If a subject is discontinued from the study with an ongoing adverse event or an unresolved clinically significant laboratory result, the clinical investigative team will attempt to provide follow-up until a satisfactory clinical resolution of the laboratory result or adverse event is achieved.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with Radiotherapy in Participants with Stable Disease or Partial Response | Other | Radiation: Ablative radiation treatmentParticipants with investigator-assessed stable disease or partial response after > 3 months of immunotherapy treatment prior to registration |
| Treatment with Radiotherapy in Patients with Oligo-progression | Other | Radiation: Ablative radiation treatmentParticipants with oligo-progression defined as having at least 3 sites of disease during their disease course, with at least 1 but up to 5 sites of progressive disease within 3 months of registration. Participants must have investigator-assessed stable disease, partial response, or complete response as prior best response to immunotherapy and have been on immunotherapy for at least 3 months prior to registration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years of age at the time of consent
- ECOG (0, 1, or 2) within 30 days prior to registration.
- Subjects with advanced solid tumors with at least 3 but no more than 10 sites of metastatic disease, excluding the primary tumor.
- Disease site must be outside of the GI tract (including esophagus, stomach, small or large bowel, and mesenteric lymph nodes), brainstem, and skin.
- Demonstrates adequate organ function. All screening labs are to be obtained within 30 days prior to registration.
Key exclusion criteria (16 listed)
- Inability to treat all sites of disease
- >10 metastatic lesions at any point in the disease course
- History of interstitial lung disease or G3 or worse pneumonitis
- Malignant pleural effusion
- Active infection requiring IV antibiotics
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 |
|---|---|---|
| Ablative radiation treatmentAblative radiation for all metastases should be completed within 3 weeks of the first dose of radiation. Metastases may be treated on an everyday or every other day schedule. | Radiation | Treatment with Radiotherapy in Participants with Stable Disease or Partial Response, Treatment with Radiotherapy in Patients with Oligo-progression |
Primary outcome
To estimate the proportion of patients with advanced tumors and polymetastatic disease on immunotherapy who achieve a molecular response (>50% ctDNA reduction) at 8 weeks following ablative radiation therapy
Time frame: Baseline to 8 weeks following the end of ablative radiation therapy
4 secondary outcomes
To evaluate 6-month and 12-month overall survival (OS)
Time frame: Registration date until the off-study date, approximately 12 months after the end of radiation therapy
To evaluate 6-month and 12-month progression-free survival (PFS)
Time frame: Registration date until the off-study date, approximately 12 months after the end of radiation therapy
To evaluate overall response rate
Time frame: Registration date until the off-study date, approximately 12 months after the end of radiation therapy
To evaluate all grades of treatment-related adverse events (TRAEs)
Time frame: Treatment start until the off-study date, approximately 12 months after the end of radiation 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 2 Mar 2026.
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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.
Ryan Nguyen, DO principal investigator
University of Illinois Chicago
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 Ablative radiation treatment in people with Advanced Solid Tumor and Metastatic Cancer, run by University of Illinois Chicago at 1 site in United States.
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 12 inclusion and 16 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 2 Mar 2026. 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 United States. 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 Ryan Nguyen, DO ((312) 996-9424, rnguye8@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the proportion of patients with advanced tumors and polymetastatic disease on immunotherapy who achieve a molecular response (>50% ctDNA reduction) at 8 weeks following ablative radiation therapy (time frame: Baseline to 8 weeks following the end of ablative radiation therapy). 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 2 Mar 2026.