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 (Jun 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
Treatments studied
Targeted therapy
Other
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 →Frequently asked questions
Is NCT06344052 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic hedgehog pathway inhibitor, radiation therapy, surgery disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify