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.
Subject has provided written informed consent prior to initiation of study-specified procedures.
Subject is 18 years of age or older.
Eastern Cooperative Oncology Group performance status 0, 1 or 2.
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).
Best response of progressive disease (primary progression).
Objective response followed by disease progression while on HHPI treatment.
laBCC with a best response of stable disease on systemic HHPI treatment.
laBCC that has recurred in the same location after two or more surgical procedures, or that has recurred following radiation therapy.