CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 92 enrolled
Drug / intervention
Part 1: VP-315 3 Day Dosing/Week +4 moredrug
Likely dose
Part 1: VP-315 3 Day Dosing/Week 8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05188729
NCT05188729Phase 2Completed
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A Phase 2, Multicenter, Open-label, Proof-of-concept Study With Safety Run-in to Evaluate the Safety, Pharmacokinetics, and Efficacy of VP-315 in Adult Subjects With Basal Cell Carcinoma

Verrica Pharmaceuticals Inc.·interventional·Posted Jan 12, 2022·Updated Jun 18, 2025

In Brief

A Phase 2 clinical trial evaluating Part 1: VP-315 3 Day Dosing/Week, Part 2: VP-315 3 Day Dosing/Week - Loading Dose, and 3 other interventions for Basal Cell Carcinoma and 4 related conditions. Completed, enrolled 92 participants across 13 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBasal Cell Carcinoma, Skin Cancer, Cancer of the Skin, Basal Cell, Cancer of the Skin, Carcinoma
CountriesUnited States
CollaboratorsInstat Clinical Research, HeartcoR Solutions, Myonex, Vial Health Technology, Inc, OncoBay Clinical, Q2 Solutions, Canfield Scientific Inc., Veristat

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJan 12, 2022
Enrollment StartFeb 1, 2022
Primary CompletionApr 15, 2024
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 4.5 years ago

Interventions

Part 1: VP-315 3 Day Dosing/Weekdrug

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 Dosedrug

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 Dosedrug

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 Dosedrug

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 Dosedrug

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).