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

Basal Cell Carcinoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06344052
Study type Interventional
Source Stamford Pharmaceuticals, Inc.
Contact Stamford Pharmaceuticals
Phone 5126944241
Email clinicaltrials@stamfordpharmaceuticals.com
Status Recruiting
Phase Phase 2
Start date April 9, 2024
Completion date March 30, 2029
View Details
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