About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Peptide Alarm Therapy (PAT)