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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
SP-002 is a replication deficient adenovirus-5 encoding human interferon gamma (IFNγ), designed for intra-tumoral administration
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.
Research Site
Phoenix, Arizona, United States
RECRUITINGResearch Site
Boca Raton, Florida, United States
RECRUITINGResearch Site
Coral Springs, Florida, United States
RECRUITINGResearch Site
Cutler Bay, Florida, United States
RECRUITINGResearch Site
Rockville, Maryland, United States
RECRUITINGResearch Site
Lee's Summit, Missouri, United States
RECRUITINGResearch Site
Rochester, New York, United States
RECRUITINGResearch Site
Cedar Park, Texas, United States
RECRUITINGResearch Site
Humble, Texas, United States
RECRUITINGResearch Site
Longview, Texas, United States
RECRUITINGObjective 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.
Time frame: Week 26
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.
Time frame: Month 36
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.
Time frame: Month 36
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.
Time frame: Month 36
Objective Response Rate (ORR) / Complete Response (CR) / Partial Response (PR)
ORR/CR/PR by investigator assessment (color photography/imaging \[RECIST-measurable\]).
Time frame: Month 36
Number of subjects discontinuing treatment with SP-002 and/or vismodegib due to toxicity.
Safety of Participants
Time frame: Month 36
Number of subjects with delays to SP-002 and/or vismodegib dosing due to toxicity.
Safety of Participants
Time frame: Month 36
Incidence and severity of SP-002 and/or vismodegib related AEs.
Safety of Participants
Time frame: Month 36
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