RecruitingMetastasisSolid Tumor
Study of PAT in Patients With Solid Tumor Cancers
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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
Sponsor: Masonic Cancer Center, University of Minnesota
You may qualify if…
- ✓ 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:
You may not qualify if…
- ✕ 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.
Where it's recruiting
Minnesota
Minneapolis
Source: ClinicalTrials.gov · NCT05338658 · last updated 2025-12-09