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

Summary

This is a 2-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, tolerability, MTD, and objective antitumor efficacy of ascending dose strengths of VP-315 when administered intratumorally to adults with biopsy proven basal cell carcinoma (BCC).

The study is expected to enroll approximately 86 subjects with a histological diagnosis of BCC in at least 1 eligible target lesion (confirmed by punch or shave biopsy).

Conditions

• Basal Cell Carcinoma
• Skin Cancer
• Cancer of the Skin, Basal Cell
• Cancer of the Skin
• Carcinoma

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).

Sponsors & Collaborators

• Instat Clinical Research

  collaborator UNKNOWN

• HeartcoR Solutions

  collaborator UNKNOWN

• Myonex

  collaborator UNKNOWN

• Vial Health Technology, Inc

  collaborator UNKNOWN

• OncoBay Clinical

  collaborator UNKNOWN

• Q2 Solutions

  collaborator INDUSTRY

• Canfield Scientific

  collaborator UNKNOWN

• Veristat

  collaborator UNKNOWN

• Verrica Pharmaceuticals Inc.

  lead INDUSTRY

Principal Investigators

• Neal Bhatia, MD · Therapeutics Clinical Research

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-01

Primary Completion

2024-04-15

Completion

2024-04-15

FDA Drug

Yes

Countries

• United States

Study Locations