Open-Label Proof of Concept Study of VP-315 in Basal Cell Carcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

February 1, 2022

Primary Completion Date

April 15, 2024

Study Completion Date

April 15, 2024

Conditions
Basal Cell CarcinomaSkin CancerCancer of the Skin, Basal CellCancer of the SkinCarcinoma
Interventions
DRUG

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.

DRUG

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.

DRUG

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).

DRUG

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).

DRUG

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).

Trial Locations (13)

15213

UPMC St. Margaret, Pittsburgh

20850

DermAssociates, Rockville

Lawrence J Green, MD LLC, Rockville

30078

Gwinnett Dermatology, Snellville

32080

Florida Center for Dermatology, Saint Augustine

33071

Life Clinical Trials, Coral Springs

33428

ClearlyDerm, Boca Raton

60181

Affinity Health, Oakbrook Terrace

77056

Austin Institute of Clinical Research - Houston, Houston

78620

Austin Institute of Clinical Research - Dripping Springs, Dripping Springs

78660

Austin Institute of Clinical Research - Pflugerville, Pflugerville

92123

Therapeutics Clinical Research, San Diego

03801

ActivMed Research - Borthwick, Portsmouth

All Listed Sponsors
collaborator

Instat Clinical Research

UNKNOWN

collaborator

HeartcoR Solutions

UNKNOWN

collaborator

Myonex

UNKNOWN

collaborator

Vial Health Technology, Inc

UNKNOWN

collaborator

OncoBay Clinical

UNKNOWN

collaborator

Q2 Solutions

INDUSTRY

collaborator

Canfield Scientific

UNKNOWN

collaborator

Veristat

UNKNOWN

lead

Verrica Pharmaceuticals Inc.

INDUSTRY

NCT05188729 - Open-Label Proof of Concept Study of VP-315 in Basal Cell Carcinoma | Biotech Hunter | Biotech Hunter