Study of PAT in Patients With Solid Tumor Cancers

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT05338658
Phase
PHASE1
Status
Recruiting
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Conditions

  • Metastasis
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Peptide Alarm Therapy (PAT) — DRUG
    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.

Study Details

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

Key Dates

Start date
May 19, 2023
Status verified
Dec 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Peptide Alarm Therapy + Pembrolizumab
    Participants receive pembrolizumab 200 mg every 3 weeks (Dose Finding Component) or a disease appropriate PD1/PD-L1 inhibitor (Dose Expansion Component) for 2 treatment courses per standard of care. The first dose of PAT is given on Day 1 and on Day 3 (36 to 48 hours after the 1st PAT dose) A second course of the PD1/PD-L1 inhibitor is given per standard of care on Day 22 (Cycle 2 Day 1).

Primary Outcome Measure

Maximum tolerated dose (MTD) of peptide alarm therapy (PAT) [ Time Frame: End of Treatment (typically at day 43) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Masonic Cancer Center at University of MinnesotaMinneapolisMinnesota55455
Melissa Geller, MD

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By research site
Masonic Cancer Center at University of Minnesota· Minneapolis, MN

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