92
Participants
Start Date
February 1, 2022
Primary Completion Date
April 15, 2024
Study Completion Date
April 15, 2024
Part 1: VP-315 3 Day Dosing/Week
2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
Part 2: VP-315 3 Day Dosing/Week - Loading Dose
4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment.
Part 2: VP-315 3 Day Dosing/Week - No Loading Dose
8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 2 Day Dosing/Week - Split Dose
8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - Split Dose
8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
UPMC St. Margaret, Pittsburgh
DermAssociates, Rockville
Lawrence J Green, MD LLC, Rockville
Gwinnett Dermatology, Snellville
Florida Center for Dermatology, Saint Augustine
Life Clinical Trials, Coral Springs
ClearlyDerm, Boca Raton
Affinity Health, Oakbrook Terrace
Austin Institute of Clinical Research - Houston, Houston
Austin Institute of Clinical Research - Dripping Springs, Dripping Springs
Austin Institute of Clinical Research - Pflugerville, Pflugerville
Therapeutics Clinical Research, San Diego
ActivMed Research - Borthwick, Portsmouth
Instat Clinical Research
UNKNOWN
HeartcoR Solutions
UNKNOWN
Myonex
UNKNOWN
Vial Health Technology, Inc
UNKNOWN
OncoBay Clinical
UNKNOWN
Q2 Solutions
INDUSTRY
Canfield Scientific
UNKNOWN
Veristat
UNKNOWN
Verrica Pharmaceuticals Inc.
INDUSTRY