protocolSection identificationModule nctId: NCT06344052, orgStudyIdInfo id: SP-002-004, briefTitle: To Assess the Safety and Efficacy of SP-002 With Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2029-03-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Stamford Pharmaceuticals, Inc., class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Basal Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: SP-002, interventions name: Vismodegib, outcomesModule primaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Progressive free survival, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR) / Complete Response (CR) / Partial Response (PR), secondaryOutcomes measure: Number of subjects discontinuing treatment with SP-002 and/or vismodegib due to toxicity., secondaryOutcomes measure: Number of subjects with delays to SP-002 and/or vismodegib dosing due to toxicity., secondaryOutcomes measure: Incidence and severity of SP-002 and/or vismodegib related AEs., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: NOT_YET_RECRUITING, city: Phoenix, state: Arizona, zip: 85006, country: United States, geoPoint lat: 33.44838, lon: -112.07404, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lee's Summit, state: Missouri, zip: 64064, country: United States, geoPoint lat: 38.91084, lon: -94.38217, locations facility: Research Site, status: RECRUITING, city: Cedar Park, state: Texas, zip: 78613, country: United States, geoPoint lat: 30.5052, lon: -97.82029, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Humble, state: Texas, zip: 77346, country: United States, geoPoint lat: 29.99883, lon: -95.26216, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Longview, state: Texas, zip: 75601, country: United States, geoPoint lat: 32.5007, lon: -94.74049, hasResults: False