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Tests treatment safety and results for Basal Cell Carcinoma
Official title To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma
ClinicalTrials.gov ID: NCT06344052
What this study is testing
What is SP-002?
SP-002 is an investigational medicine, given as an once-daily, being studied as a potential treatment for basal cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- Subject has a single lesion that is histologically confirmed as BCC. The externally visible component of the lesions should be at least 1 cm in one...
- 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...
You likely can't join if
- 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.
- laBCC that has recurred in the same location after two or more surgical procedures, or that has recurred following radiation therapy.
- laBCC that has bone involvement (radiologically confirmed if clinically suspected).
See the full eligibility criteria
- 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.
- Subject has a single lesion that is histologically confirmed as BCC. The externally visible component of the lesions should be at least 1 cm in one dimension to facilitate accurate and reproducible measurement, to 5 cm...
- 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).
- Medical conditions predisposing to poor surgical outcome (e.g., diabetes with history of poor wound healing).
- Other conditions considered to be medically contraindicating must be discussed with the Medical Monitor before enrolling the subject. A copy of the surgical consultation note must be provided. laBCC with prior history...
- Achieved objective response with disease progression \>3 months after treatment discontinuation.
- Achieve best response of PR with persistent disease that continues to meet study and has been off treatment for at least 3 months. Note: where the subject has \>1 lesion, one lesion may be selected for treatment at the...
- Radiotherapy is contraindicated or inappropriate in the opinion of the investigator, for example, hypersensitivity to radiation due to genetic syndrome such as Gorlin syndrome, limitations because of location of tumor...
- Subject is able and willing to comply with all study requirements including biopsies at baseline and during the study. Biopsy 3-4 mm preferred, biopsies must be \<25% of the area the tumor. Screening biopsies performed...
- 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 × the upper limit of normal (ULN) or within 3 × the ULN for patients with Gilbert disease
- Aspartate aminotransferase, alanine aminotransferase or alkaline phosphate \<2 × the ULN
- Adequate renal function, as defined by the following:
- Creatinine \<1.5 x ULN
- For female people of childbearing potential\ , agreement to use two acceptable methods of contraception (including one barrier method), during the study and for at least (per United States Prescribing Information...
- people agree not to donate blood or blood products during the study and for at least (per USPI) 24 months after discontinuation of vismodegib; male people agree not to donate sperm during the study and for at least 2...
- Childbearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal. Menopause is defined as...
- 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.
- laBCC that has recurred in the same location after two or more surgical procedures, or that has recurred following radiation therapy.
- laBCC that has bone involvement (radiologically confirmed if clinically suspected).
- laBCC with invasion of underlying soft tissue that is not accessible by standard syringe/needle.
- Patients with evidence of metastatic BCC.
- Female people who are lactating or pregnant.
- Life expectancy of \<12 weeks.
- Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, or radiation therapy).
- Recent (within 4 weeks of Day 1), current, or planned participation in an experimental drug study.
- History of other malignancies within 3 years of Day 1, except for tumors with a negligible risk for metastasis or death, such as adequately treated basal and squamous-cell carcinoma of the skin, ductal carcinoma in situ...
- Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics.
- History of other stable disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Boca Raton, Florida, United States
- Coral Springs, Florida, United States
- Cutler Bay, Florida, United States
- Rockville, Maryland, United States
- Lee's Summit, Missouri, United States
- Rochester, New York, United States
- Cedar Park, Texas, United States
- Humble, Texas, United States
- Longview, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Boca Raton, Florida, United States; Coral Springs, Florida, United States; Cutler Bay, Florida, United States; Rockville, Maryland, United States; Lee's Summit, Missouri, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.