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.
Parallel
SP-002
DrugSP-002 is a replication deficient adenovirus-5 encoding human interferon gamma (IFNγ), designed for intra-tumoral administration
Vismodegib
DrugThe 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.
Objective response rate
ORR defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) of the target lesion based on central review at any time point.
Duration of response
DOR defined as the time interval between the date of first response (CR or PR) of the target lesion to the date of disease progression or death from any cause. Disease progression as assessed by central review.
Progressive free survival
PFS defined as the time interval between the date of randomization/start of treatment to the date of first documented progression of the target tumor or death. If a subject has not had an event, PFS is censored at the date of last adequate tumor assessment. Rate of disease progression of the target tumor as assessed by central review.
Overall survival (OS)
OS defined as the time interval between the date of randomization and the date of death. If a subject has not had an event, the patient will be censored at the date of the last study visit attended.
Objective Response Rate (ORR) / Complete Response (CR) / Partial Response (PR)
ORR/CR/PR by investigator assessment (color photography/imaging \[RECIST-measurable\]).
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