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
Masonic Cancer Center, University of Minnesota
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugPeptide Alarm Therapy (PAT)
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.
Location
- Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota