OncoMatch/Clinical Trials/NCT06344052
To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma
Is NCT06344052 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including SP-002 and Vismodegib for basal cell carcinoma.
Treatment: SP-002 · Vismodegib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic hedgehog pathway inhibitor
Exception: Patients with prior history of or ongoing HPPI treatment are eligible if: achieved objective response with disease progression >3 months after treatment discontinuation, or best response of PR with persistent disease and off treatment for at least 3 months.
laBCC that has progressed on systemic HHPI therapy as defined below: 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.
Cannot have received: radiation therapy
Exception: Radiotherapy is contraindicated or inappropriate in the opinion of the investigator
laBCC that has recurred following radiation therapy
Cannot have received: surgery
Exception: Not a good candidate for surgery or has recurred after definitive surgical treatment and curative surgical resection is unlikely; or medical contraindication to surgery
laBCC that has recurred in the same location after two or more surgical procedures
Lab requirements
Blood counts
Neutrophil count >1,500/mm3; Hemoglobin >9 g/dL; Platelet count >100,000/ mm3; Prothrombin international normalized ratio <1.5
Kidney function
Creatinine <1.5 x ULN
Liver function
Total bilirubin <1.5 × ULN or within 3 × ULN for patients with Gilbert disease; AST, ALT or alkaline phosphate <2 × ULN
Subject has adequate hematopoietic capacity, as defined by the following: Neutrophil count >1,500/mm3; Hemoglobin >9 g/dL; Platelet count >100,000/ mm3; Prothrombin international normalized ratio <1.5. Subject has adequate hepatic function, as defined by the following: Total bilirubin <1.5 × ULN or within 3 × ULN for patients with Gilbert disease; AST, ALT or alkaline phosphate <2 × ULN. Adequate renal function, as defined by the following: Creatinine <1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Phoenix, Arizona
- Research Site · Boca Raton, Florida
- Research Site · Coral Springs, Florida
- Research Site · Cutler Bay, Florida
- Research Site · Rockville, Maryland
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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