NCT06344052 To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma
| NCT ID | NCT06344052 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Stamford Pharmaceuticals, Inc. |
| Condition | Basal Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-04-09 |
| Primary Completion | 2026-09-30 |
Trial Parameters
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Brief 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 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 surgical treatment and curative surgical resection is unlikely. OR B. subject has a medical contraindication to surgery where acceptable medical contraindications to surgery include: * Anticipated substantial morbidity and/or deformity from surgery (e.g., removal of all or part of a vital facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation). * Medical conditions predisp