What side effects are associated with this type of intervention?

Common treatments for Basal Cell Carcinoma (BCC) include surgical excision, Mohs micrographic surgery, cryotherapy, topical treatments (like imiquimod and 5-fluorouracil), and photodynamic therapy. For treatments similar to VP-315, which involves direct intratumoral injections, side effects can include localized pain, swelling, redness, and potential infection at the injection site. Systemic side effects are generally minimal due to the localized nature of the treatment. Broadly, other treatments may cause scarring, changes in skin pigmentation, and, in rare cases, more severe reactions depending on the patient's overall health and the specific treatment used.

What prior FDA approvals exist?

The FDA has approved several treatments for Basal Cell Carcinoma (BCC), including topical therapies, oral medications, and surgical options. Notably, vismodegib and sonidegib are oral hedgehog pathway inhibitors approved for advanced BCC. While direct intratumoral injections like VP-315 are being studied, current FDA-approved treatments primarily include non-injection methods. Topical treatments such as imiquimod and 5-fluorouracil are also used for superficial BCC. Surgical options, including Mohs micrographic surgery, remain the standard for many cases of BCC.

What other types of research exist?

Promising novel alternatives to VP-315 for Basal Cell Carcinoma patients include: 1) Sonidegib and Vismodegib, which are Hedgehog pathway inhibitors approved for advanced BCC. 2) Cemiplimab, an anti-PD-1 monoclonal antibody showing efficacy in advanced BCC. 3) Talimogene laherparepvec (T-VEC), an oncolytic virus therapy under investigation for BCC. These treatments offer different mechanisms of action and have shown promising results in clinical trials.

← Back to Search

Virus Therapy

VP-315 / LTX-315 for Skin Cancer

Q: What is the mechanism of action of this treatment?

The most common treatments for Basal Cell Carcinoma (BCC) include surgical excision, topical therapies, and more recently, direct intratumoral injections like those studied in the VP-315 trial. Direct intratumoral injections, such as VP-315, work by delivering therapeutic agents directly into the tumor, which can induce localized antitumor activity. This method often involves the use of agents that stimulate the immune system to attack cancer cells or directly cause cancer cell death. This approach is significant for BCC patients as it targets the tumor precisely, potentially reducing systemic side effects and improving the efficacy of the treatment. Additionally, it offers a non-surgical option, which can be particularly beneficial for patients who are not good candidates for surgery.

Phase 2

Waitlist Available

Led By Neal Bhatia, MD

Research Sponsored by Verrica Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For punch biopsies: the size of the lesion(s) must be ≥0.5 cm and </=2 cm in the longest diameter prior to punch biopsy

Willing to practice a highly effective method of birth control while on study and until 4 weeks after the last treatment. Highly effective birth control includes sexual abstinence, vasectomy, bilateral tubal ligation/occlusion, or a condom with spermicide (men) combined with hormonal birth control or intrauterine device in women

Must not have

Histological evidence of infiltrative, desmoplastic, sclerosing, or morpheaform BCC subtypes in the biopsy specimen

Genetic or nevoid conditions (eg, Gorlin / basal cell nevus syndrome, xeroderma pigmentosum)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 84-91

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing VP-315, a treatment injected directly into skin cancer tumors. It targets adults with basal cell carcinoma. The goal is to see if these injections can safely and effectively shrink or eliminate the tumors.

Who is the study for?

Adults over 18 with suspected basal cell carcinoma (BCC) suitable for biopsy and excision can join this trial. They must have 1-5 lesions, avoid sun/UV light, use effective birth control, and not apply nonapproved topical agents near the lesions. Excluded are those with high-risk BCCs, recent surgeries or treatments, certain chronic conditions or drug abuse.

What is being tested?

The study tests VP-315 Part 2 and LTX-315 Part 1 drugs on people with basal cell carcinoma by injecting them directly into tumors to see how safe they are and how well they work at different doses. It's an open-label trial where everyone knows what treatment they're getting.

What are the potential side effects?

Possible side effects of VP-315 and LTX-315 may include reactions at the injection site like pain or swelling, general skin irritation around treated areas, fatigue from treatment sessions, or other immune-related responses due to the nature of these cancer-fighting drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My lesion is between 0.5 cm and 2 cm in size before a biopsy.

Select...

I will use effective birth control during and 4 weeks after the study.

Select...

I am willing to avoid direct sunlight and tanning parlors during the study.

Select...

I am willing to have surgery for my basal cell carcinoma after the study treatment.

Select...

I have 1 to 5 skin lesions suspected to be basal cell carcinoma, suitable for removal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My biopsy shows I have a specific type of skin cancer.

Select...

I have a genetic condition like Gorlin syndrome or xeroderma pigmentosum.

Select...

My lesions are near sensitive areas like eyes, lips, or on hands, feet, ears, nose, and genitals.

Select...

My cancer has come back or was treated before.

Select...

I have not had and do not plan any elective surgery around the study period.

Select...

My skin cancer is considered medium or high risk.

Select...

My biopsy shows signs of another type of tumor.

Select...

I have or might have cancer that has spread in my body.

Select...

I haven't had chemotherapy in the last 6 months.

Select...

I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 84-91

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 84-91

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 84-91 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: Percentage of subjects with Cutaneous Reaction by severity

Part 1: Percentage of subjects with discontinuations due to adverse events

Part 1: Percentage of subjects with dose-limiting toxicities (DLTs)

+4 more

Secondary study objectives

Part 2 (Cohorts 4 and 5 expansion groups): Plasma concentrations of VP-315

Part 2: Mean estimated remaining tumor volume at excision

Part 2: Percent of subjects with Physician's Global Assessment by scale

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2 VP-315 Regimen FindingExperimental Treatment1 Intervention

Part 2: VP-315 once-daily dosing; total daily dose of 8 mg in up to 5 cohorts * Cohort 1: VP-315 once-daily dosing of 8 mg with half the target dose of 8 mg only on W1D1; all remaining doses will be the full target dose * Cohort 2: VP-315 once-daily dosing of 8 mg on all treatment days for up to 3 consecutive daily doses/week. * Cohort 3: has been removed, advance from Cohort 2 to 4 and 5. Cohorts 4 and 5, the total daily dose of VP-315 (8.0 mg) will be divided into a split dose; the first dose is not to exceed 2.4 mg (30% of 8 mg dose), and the remaining dose will not exceed 5.6 mg (70% of 8 mg dose) and administered 15 minutes apart (not to exceed 30 minutes). * Cohort 4: (Two times weekly dosing) VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week. * Cohort 5: (Three times weekly dosing) VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week. PK data will be collected in the Cohorts 4 and 5 expansion groups.

Group II: Part 1 LTX-315 Safety Run-inExperimental Treatment1 Intervention

Part 1: Starting total daily dose of LTX-315 will be 2 mg for the first subject. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week until the first lesion is necrosed or a DLT occurs

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VP-315 Part 2

2022

Completed Phase 2

~100

LTX-315 Part 1

2022

Completed Phase 2

~100

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Basal Cell Carcinoma (BCC) include surgical excision, topical therapies, and more recently, direct intratumoral injections like those studied in the VP-315 trial. Direct intratumoral injections, such as VP-315, work by delivering therapeutic agents directly into the tumor, which can induce localized antitumor activity. This method often involves the use of agents that stimulate the immune system to attack cancer cells or directly cause cancer cell death. This approach is significant for BCC patients as it targets the tumor precisely, potentially reducing systemic side effects and improving the efficacy of the treatment. Additionally, it offers a non-surgical option, which can be particularly beneficial for patients who are not good candidates for surgery.