MetastasisPhase 1NCT05338658
Study of PAT in Patients With Solid Tumor Cancers
A Phase 1 study testing Peptide Alarm Therapy (PAT) in people with Metastasis and Solid Tumor, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This is a single center Phase I study with extension of peptide alarm therapy (PAT) administered by intratumoral (IT) injection during the 1st course of a standard of care intravenous PD-1/PD-L1 inhibitor for the treatment of locally advanced or metastatic solid tumor cancers that has failed to be controlled after one… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastasis, Solid Tumor
- What is being tested?
- Peptide Alarm Therapy (PAT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2023to Jan 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
- Must be seropositive for CMV and EBV.
- Must have at least one HLA-A*0201 allele. This screening can be performed after determining CMV and EBV seropositivity is established or, if available, from the results of previous tumor profiling by any CLIA-certified lab (i.e. Caris, FoundationOne).
- 18 years or older at the time of signing the pre-screening consent.
- ECOG Performance Status 0 or 1.
- Adequate organ function within 14 days of study enrollment
- Cardiac: New York Heart Association (NYHA) Functional Classification Class I.
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- Pulmonary: oxygen saturation ≥ 90% on room air.
- Time between last dose of prior anti-cancer therapy and Day 1 of this study:
- Chemotherapy: a minimum of 28 days since last treatment.
- Targeted therapy, immunotherapy, investigational agents: a minimum of 45 days since last dose (at least 2 months for anti-VEGF)
- Prior palliative radiotherapy within 7 days of start of study treatment. Participants must have recovered from all radiation-related toxicities (prior irradiation to targeted lesions is not permitted)
- Must have recovered to CTCAE ≤Grade 1 from previous treatment related acute toxicities.
- Persons of childbearing potential or with partners of childbearing potential must be willing to abstain from heterosexual activity or to use a highly effect form of contraception from the time of study enrollment until at least 4 months after the last dose of PD-1/PD-L1 inhibitor.
- Able to understand and provide voluntary written consent prior to the performance of any research related activity.
Who cannot join
- Pregnant or breast feeding.
- Requires therapeutic anticoagulation for which it is deemed unsafe to discontinue anticoagulation for 5 days prior to Cycle 1 through Day 7 of Cycle 1
- Class II or greater New York Heart Association Functional Classification criteria or serious cardiac arrhythmias likely to increase the risk of cardiac complications of therapy (e.g. ventricular tachycardia, frequent ventricular ectopy, or supraventricular tachyarrhythmia requiring chronic therapy)
- Known active CNS metastases
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- Has received a live vaccine within 30 days prior to the first dose of study drug.
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- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to study enrollment.
- Prior bone marrow and/or solid organ transplant.
- Has severe hypersensitivity (≥Grade 3) to prior PD-1/PD-L1 and/or any of its excipients.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.
- Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR
- Known history of active TB (Bacillus Tuberculosis)
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- Has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the treating investigator.
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
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
Melissa Geller, MD
About this study
Official title: Phase I Study of Peptide Alarm Therapy (PAT) Administered by Intratumoral Injection With a PD-1/PD-L1 Inhibitor in Patients With Solid Tumor Cancers Who Have Failed 1 or More Prior Therapies
This is a single center Phase I study with extension of peptide alarm therapy (PAT) administered by intratumoral (IT) injection during the 1st course of a standard of care intravenous PD-1/PD-L1 inhibitor for the treatment of locally advanced or metastatic solid tumor cancers that has failed to be controlled after one or more prior therapies including a previous PD-1/PD-L1 inhibitor
- Conditions
- Metastasis, Solid Tumor
- Being tested
- Peptide Alarm Therapy (PAT)
- Keywords
- PAT
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptide Alarm Therapy (PAT)Drug
Also called Pembrolizumab
PAT is given on Day 1 by IT injection after the 1st anti PD-1/PD-L1 infusion and again 36-48 hours later on Day 3.
| Study group | Role | What they receive |
|---|---|---|
| Peptide Alarm Therapy + Pembrolizumab | Experimental | Participants receive pembrolizumab 200 mg every 3 weeks (Dose Finding Component) or a disease appropriate PD1/PD-L1 inhibitor (Dose Expansion Component) for 2 treatment courses per standard of care.
The first dose of PAT is given on Day 1 and on Day 3 (36 to 48 hours after the 1st PAT dose)
A second course of the PD1/PD-L1 inhibitor is given per standard of care on Day 22 (Cycle 2 Day 1). Receives: Drug: Peptide Alarm Therapy (PAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of peptide alarm therapy (PAT)
Use CTCAE v5 criteria to count toxicities per patient including proportions and their 95% confidence intervals will be calculated
Measured: End of Treatment (typically at day 43)
Secondary outcomes (1)
Progression free survival (PFS)
Kaplan-Meier curves will be used to estimate with a 95% confidence interval.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start19 May 2023
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetastasisStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Geller, MD, Principal investigator, Masonic Cancer Center, Univeristy of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338658
- Sponsor's protocol ID
- 2021LS105
- Status last verified
- Dec 2025
- First submitted
- 14 Apr 2022
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Peptide Alarm Therapy (PAT) Administered by Intratumoral Injection With a PD-1/PD-L1 Inhibitor in Patients With Solid Tumor Cancers Who Have Failed 1 or More Prior Therapies
- ClinicalTrials.gov ID
- NCT05338658
- Acronym / sponsor ID
- 2021LS105
- Conditions
- Metastasis, Solid Tumor
- Keywords
- PAT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 21 Apr 2022 (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 single center Phase I study with extension of peptide alarm therapy (PAT) administered by intratumoral (IT) injection during the 1st course of a standard of care intravenous PD-1/PD-L1 inhibitor for the treatment of locally advanced or metastatic solid tumor cancers that has failed to be controlled after one or more prior therapies including a previous PD-1/PD-L1 inhibitor
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peptide Alarm Therapy + Pembrolizumab | Experimental | Drug: Peptide Alarm Therapy (PAT)Participants receive pembrolizumab 200 mg every 3 weeks (Dose Finding Component) or a disease appropriate PD1/PD-L1 inhibitor (Dose Expansion Component) for 2 treatment courses per standard of care. The first dose of PAT is given on Day 1 and on Day 3 (36 to 48 hours after the 1st PAT dose) A second course of the PD1/PD-L1 inhibitor is given per standard of care on Day 22 (Cycle 2 Day 1). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Must be seropositive for CMV and EBV.
- Must have at least one HLA-A*0201 allele. This screening can be performed after determining CMV and EBV seropositivity is established or, if available, from the results of previous tumor profiling by any CLIA-certified lab (i.e. Caris, FoundationOne).
- 18 years or older at the time of signing the pre-screening consent.
- ECOG Performance Status 0 or 1.
- Adequate organ function within 14 days of study enrollment
Key exclusion criteria (15 listed)
- Pregnant or breast feeding.
- Requires therapeutic anticoagulation for which it is deemed unsafe to discontinue anticoagulation for 5 days prior to Cycle 1 through Day 7 of Cycle 1
- Class II or greater New York Heart Association Functional Classification criteria or serious cardiac arrhythmias likely to increase the risk of cardiac complications of therapy (e.g. ventricular tachycardia, frequent ventricular ectopy, or supraventricular tachyarrhythmia requiring chronic therapy)
- Known active CNS metastases
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
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 |
|---|---|---|
| Peptide Alarm Therapy (PAT)Also: PembrolizumabPAT is given on Day 1 by IT injection after the 1st anti PD-1/PD-L1 infusion and again 36-48 hours later on Day 3. | Drug | Peptide Alarm Therapy + Pembrolizumab |
Primary outcome
Maximum tolerated dose (MTD) of peptide alarm therapy (PAT)
Time frame: End of Treatment (typically at day 43)
Use CTCAE v5 criteria to count toxicities per patient including proportions and their 95% confidence intervals will be calculated
1 secondary outcome
Progression free survival (PFS)
Time frame: 6 Months
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 9 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.
Melissa Geller, MD principal investigator
Masonic Cancer Center, Univeristy of Minnesota
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 Peptide Alarm Therapy (PAT) in people with Metastasis and Solid Tumor, run by Masonic Cancer Center, University of Minnesota 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 14 inclusion and 15 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 9 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 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 Cancer Center Clinical Trials Office (612 624 2620, ccinfo@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) of peptide alarm therapy (PAT) (time frame: End of Treatment (typically at day 43)). 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 9 Dec 2025.