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

Stamford Pharmaceuticals, Inc.

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.

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 partic…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Subject has provided written informed consent prior to initiation of study-specified procedures. 2. Subject is 18 years of age or older. 3. Eastern Cooperative Oncology Group performance status 0, 1 or 2. 4. Subject has a single lesion that is histologically confirmed as BCC. The externally visible component of the lesions should be at least 1 cm in one dimension to facilitate accurate and reproducible measurement, to 5 cm at longest diameter, that in the opinion of the investigator: A. is considered not a good candidate for surgery or has recurred after definitive…

Interventions

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.

Locations (10)

Research Site
Phoenix, Arizona
Research Site
Boca Raton, Florida
Research Site
Coral Springs, Florida
Research Site
Cutler Bay, Florida
Research Site
Rockville, Maryland
Research Site
Lee's Summit, Missouri