RecruitingPhase 2NCT06344052

To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma

A Phase 2 Study to Assess the Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma

Sponsor

Stamford Pharmaceuticals, Inc.

Enrollment

80 participants

Start Date

Apr 9, 2024

Study Type

INTERVENTIONAL

Conditions

Basal Cell Carcinoma

Summary

The goal of this clinical trial is to evaluate the efficacy of using SP-002 in participants with locally advanced Basal cell carcinoma. The main question it aims to answer is what the objective response rate for a basal cell carcinoma tumor is following 1 or 3 cycles of SP-002 treatment given as an add-on to hedgehog pathway inhibitor therapy. Researchers will compare the objective response rate for treated Basal cell carcinoma tumors between 3 treatment Arms. * Arm 1 participants will receive daily hedgehog pathway inhibitor, and 3 cycles of SP-002 treatment. * Arm 2 participants will receive daily hedgehog pathway inhibitor, and 1 cycle of SP-002 treatment. * Arm 3 participants will receive daily hedgehog pathway inhibitor only.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining a topical drug applied directly to the skin (SP-002) with vismodegib (an oral medication) is safe and effective for treating locally advanced basal cell carcinoma — a common skin cancer that has grown too large or in a difficult location to be removed by surgery. **You may be eligible if...** - You are 18 or older - You have a single confirmed basal cell carcinoma lesion that is between 1 cm and 5 cm in size - Surgery is not suitable for you — either because surgery would cause major disfigurement, you have medical conditions making surgery too risky, or the cancer has come back after surgery - Your general health is adequate (ECOG 0–2) **You may NOT be eligible if...** - You have multiple basal cell carcinoma lesions to be treated - Your lesion is smaller than 1 cm (too small to measure accurately) - You are unable to provide consent - You have conditions that make you ineligible per the investigator's assessment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSP-002

SP-002 is a replication deficient adenovirus-5 encoding human interferon gamma (IFNγ), designed for intra-tumoral administration

DRUGVismodegib

The HHPI vismodegib is currently indicated for the treatment of adult patients with metastatic BCC, or with laBCC where surgery and/or radiation therapy are not appropriate.