Open-Label Study of VP-315 for Treating Basal Cell Carcinoma

Sponsor: Verrica Pharmaceuticals Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05188729

Provider View

This clinical trial is testing a new treatment called VP-315 for adults with basal cell carcinoma (BCC), a common type of skin cancer. The study aims to find out if VP-315 is safe and effective when injected directly into the tumor.

Patient Parameters

Program Overview

This study is designed to test the safety and effectiveness of a new treatment, VP-315, for adults with basal cell carcinoma (BCC). The treatment involves injecting VP-315 directly into the tumor. The study will include about 80 participants who have been diagnosed with BCC through a biopsy. Participants will receive the treatment on an outpatient basis, meaning they won't need to stay in the hospital. The treatment schedule includes up to three consecutive days of injections each week, followed by a break of at least four days. The study will monitor how the tumors respond to the treatment and any side effects that occur.

Description

This clinical trial is exploring a new treatment called VP-315 for adults with basal cell carcinoma (BCC), a type of skin cancer. The study is open-label, meaning both the researchers and participants know what treatment is being given. It will take place at multiple centers and will involve two parts. The goal is to determine the safety, tolerability, and effectiveness of different doses of VP-315 when injected directly into the tumor.

Participants will receive VP-315 injections into up to two target lesions. Each treatment week consists of up to three consecutive days of injections, followed by a break of at least four days. If a tumor is observed to be fully necrotic (dead), treatment of that lesion will stop, and treatment of another lesion may begin the following week. In some cases, treatment of a second lesion will start regardless of the first lesion's status.

The study will enroll about 80 adults who have been diagnosed with BCC through a biopsy. Participants must be willing to follow certain guidelines, such as avoiding non-approved topical agents on the treatment area and staying out of direct sunlight during the study. They must also agree to delay any surgical removal of the cancer until after the study treatment is completed.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Have at least one basal cell carcinoma (BCC) lesion suitable for biopsy and removal.
  • Willing to avoid using non-approved topical agents near the BCC lesions during treatment.
  • Agree to avoid direct sunlight and tanning beds during the study.
  • Provide written consent for participation and for tissue samples to be examined.
  • Agree to have BCC lesions surgically removed after the study treatment.
  • Allow photographs of the BCC lesions for study purposes.
  • Use effective birth control during the study and for four weeks after the last treatment.

BCC Lesion Inclusion:

  • Lesion size must be between 0.5 cm and 2 cm in diameter before biopsy.
  • Diagnosis of specific BCC types confirmed by biopsy within 28 days before starting treatment.

Exclusion Criteria

  • Have known or suspected systemic cancer.
  • Received chemotherapy within six months before the study.
  • Used immunotherapy or immunosuppressants within 12 weeks before the study.
  • Have genetic conditions like Gorlin syndrome or xeroderma pigmentosum.
  • Have significant lab abnormalities or chronic medical conditions that could interfere with the study.
  • Have a history of certain infections or autoimmune diseases requiring treatment.
  • Have known allergies to the study medication.
  • Had elective surgery within four weeks before the study.
  • Have a history of alcohol or drug abuse.
  • Are currently in another clinical trial.
  • Are pregnant or breastfeeding.

BCC Lesion Exclusion:

  • Lesions that have been treated before.
  • Lesions near sensitive areas like eyelids, lips, hands, feet, ears, nose, or genitals.
  • Lesions with other tumor types or specific BCC subtypes.
  • Medium- or high-risk BCCs as defined by medical guidelines.
  • Lesions on lower extremities in patients with severe skin conditions.
  • Recent treatment with certain topical agents or procedures near the lesion.
  • History of skin cancer near the target lesion.

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