Study of PAT in Patients With Solid Tumor Cancers

Last updated: December 8, 2025
Sponsor: Masonic Cancer Center, University of Minnesota
Overall Status: Active - Recruiting

Phase

1

Condition

Neuroblastoma

Neoplasms

Neoplasm Metastasis

Treatment

Peptide Alarm Therapy (PAT)

Clinical Study ID

NCT05338658
2021LS105
  • Ages > 18
  • All Genders

Study 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 or more prior therapies including a previous PD-1/PD-L1 inhibitor

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must be seropositive for CMV and EBV.

  • Must have at least one HLA-A*0201 allele. This screening can be performed afterdetermining CMV and EBV seropositivity is established or, if available, from theresults 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 dayssince 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 (priorirradiation to targeted lesions is not permitted)

  • Must have recovered to CTCAE ≤Grade 1 from previous treatment related acutetoxicities.

  • Persons of childbearing potential or with partners of childbearing potential must bewilling to abstain from heterosexual activity or to use a highly effect form ofcontraception from the time of study enrollment until at least 4 months after thelast dose of PD-1/PD-L1 inhibitor.

  • Able to understand and provide voluntary written consent prior to the performance ofany research related activity.

Exclusion

Exclusion Criteria:

  • Pregnant or breast feeding.

  • Requires therapeutic anticoagulation for which it is deemed unsafe to discontinueanticoagulation for 5 days prior to Cycle 1 through Day 7 of Cycle 1

  • Class II or greater New York Heart Association Functional Classification criteria orserious cardiac arrhythmias likely to increase the risk of cardiac complications oftherapy (e.g. ventricular tachycardia, frequent ventricular ectopy, orsupraventricular tachyarrhythmia requiring chronic therapy)

  • Known active CNS metastases

  • Has active autoimmune disease that has required systemic treatment in the past 2years (i.e. with use of disease modifying agents, corticosteroids orimmunosuppressive 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 (indosing exceeding 10 mg daily of prednisone equivalent) or any other form ofimmunosuppressive 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 itsexcipients.

  • Has a history of (non-infectious) pneumonitis that required steroids or has currentpneumonitis.

  • Has an active infection requiring systemic therapy.

  • Known seropositive for HIV or known active Hepatitis B or C infection withdetectable viral load by PCR

  • Known history of active TB (Bacillus Tuberculosis)

  • Is currently participating in or has participated in a study of an investigationalagent or has used an investigational device within 4 weeks prior to the first doseof study treatment.

  • Has uncontrolled intercurrent illness including, but not limited to, ongoing oractive infection, interstitial lung disease, non-infectious pneumonitis, symptomaticcongestive heart failure, unstable angina pectoris, cardiac arrhythmia, orpsychiatric illness/social situations that would limit compliance with studyrequirements in the opinion of the treating investigator.

Study Design

Total Participants: 21
Treatment Group(s): 1
Primary Treatment: Peptide Alarm Therapy (PAT)
Phase: 1
Study Start date:
May 19, 2023
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Masonic Cancer Center at University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Masonic Cancer Center at University of Minnesota

    Minneapolis 5037649, Minnesota 5037779 55455
    United States

    Active - Recruiting

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