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Study of Peptide Alarm Therapy (PAT) for Solid Tumor Cancers

This study is testing a treatment called Peptide Alarm Therapy (PAT) for people with advanced solid tumor cancers that have not responded to previous treatments, including a type of immunotherapy called PD-1/PD-L1 inhibitors. PAT is given by injection directly into the tumor (intratumoral injection) along with the standard PD-1/PD-L1 inhibitor. Researchers want to find the highest safe dose of PAT. To join, you must be at least 18 years old, have certain viruses (CMV and EBV) in your system, and a specific genetic marker (HLA-A*0201). This study is currently unclear about its recruitment status and plans to enroll 21 participants.

Study design
This is a single-center Phase I study, meaning it's an early-stage study focused on safety, with an extension. It plans to enroll 21 participants.
What's involved
You would receive PAT by injection into your tumor on Day 1 and Day 3, along with your standard PD-1/PD-L1 inhibitor infusion.
Compensation
Not stated in the trial record.
Follow-up
The primary goal of the study, finding the maximum tolerated dose, is measured at the end of treatment, typically around day 43.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05338658

Study of PAT in Patients With Solid Tumor Cancers

Recruiting
PHASE1Ages 18+InterventionalTreatment
Masonic Cancer Center, University of Minnesota
~21 participants
Updated 2025-12-09 on ClinicalTrials.gov
What's tested:Peptide Alarm Therapy (PAT)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose (MTD) of peptide alarm therapy (PAT)
Measured over End of Treatment (typically at day 43)

Conditions

Metastasis
Solid Tumor

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Solid NeoplasmCytomegaloviral InfectionHLA Class I Histocompatibility Antigen, A-0201 Alpha ChainX-linked Lymphoproliferative Syndrome 1

NCT05338658

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Masonic Cancer Center at University of Minnesota

    Minneapolis, Minnesotano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Melissa Geller, MD · PRINCIPAL_INVESTIGATOR · Masonic Cancer Center, Univeristy of Minnesota

Who to contact

Cancer Center Clinical Trials Office
[email protected]
612 624 2620
Email the study team

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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.
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.

What this trial measures

  • Maximum tolerated dose (MTD) of peptide alarm therapy (PAT)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