NCT06344052

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Stamford Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 2, 3-arm, multi-center, open-label, randomized, clinical study to evaluate the efficacy of SP-002 in combination with vismodegib in subjects with locally advanced Basal cell carcinoma. The study will be completed in 2 consecutive parts. Each part consists of a screening period, a treatment period, and a follow-up period. * Part A: 20 participants who meet study entry criteria will be randomized in a 1:1 ratio into 2 treatment arms (Arm 2 and Arm 3) and will provide preliminary safety and performance in a population with target Basal cell carcinoma lesions. * Part B: 60 participants who meet study entry criteria will be randomized in a 1:1:1 ratio into 3 treatment arms (Arm 1, Arm 2, and Arm 3) in a population with target Basal cell carcinoma lesions.

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	SP-002	SP-002 is a replication deficient adenovirus-5 encoding human interferon gamma (IFNγ), designed for intra-tumoral administration
DRUG	Vismodegib	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.

Timeline

• Start date: 2024-04-09
• Primary completion: 2026-09-30
• Completion: 2029-03-30
• First posted: 2024-04-03
• Last updated: 2024-09-20

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study