Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05338658

Study of PAT in Patients With Solid Tumor Cancers

Led by Masonic Cancer Center, University of Minnesota · Updated on 2025-12-09

21

Participants Needed

1

Research Sites

189 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Study of PAT in Patients With Solid Tumor Cancers

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must be seropositive for CMV and EBV.
  • Must have at least one HLA-A*0201 allele.
  • Age 18 years or older at the time of signing the pre-screening consent.
  • ECOG Performance Status of 0 or 1.
  • Adequate organ function within 14 days prior to enrollment.
  • Cardiac status classified as New York Heart Association (NYHA) Class I.
  • Pulmonary oxygen saturation of 90% or higher on room air.
  • Minimum 28 days since last chemotherapy treatment before Day 1.
  • Minimum 45 days since last targeted therapy, immunotherapy, or investigational agent (at least 2 months for anti-VEGF).
  • No prior palliative radiotherapy within 7 days before study treatment and full recovery from radiation toxicities.
  • Recovery to CTCAE Grade 1 or less from previous treatment-related acute toxicities.
  • Willingness to abstain from heterosexual activity or use highly effective contraception from enrollment until 4 months after last PD-1/PD-L1 inhibitor dose.
  • Ability to understand and provide voluntary written consent before any research activity.
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding.
  • Requires therapeutic anticoagulation unsafe to stop 5 days prior to Cycle 1 through Day 7.
  • New York Heart Association Functional Class II or higher or serious cardiac arrhythmias increasing risk.
  • Known active central nervous system metastases.
  • Active autoimmune disease needing systemic treatment within past 2 years.
  • Received live vaccine within 30 days prior to first study drug dose.
  • Immunodeficiency diagnosis or chronic systemic steroid therapy exceeding 10 mg prednisone daily or other immunosuppressive therapy within 7 days prior to enrollment.
  • Prior bone marrow or solid organ transplant.
  • Severe hypersensitivity (Grade 3 or higher) to prior PD-1/PD-L1 therapy or excipients.
  • History or current pneumonitis requiring steroids.
  • Active infection requiring systemic therapy.
  • Known HIV seropositivity or active Hepatitis B or C with detectable viral load.
  • History of active tuberculosis.
  • Participation in investigational agent/device study within 4 weeks before first dose.
  • Uncontrolled illnesses including active infection, lung disease, heart failure, unstable angina, arrhythmias, or psychiatric/social conditions limiting compliance.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

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Research Team

C

Cancer Center Clinical Trials Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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