Back to search results

SP-002 with Vismodegib for Locally Advanced Basal Cell Carcinoma

This study is testing a new treatment for locally advanced basal cell carcinoma (a type of skin cancer). It combines SP-002, a treatment given directly into the tumor, with vismodegib, a medication already used for this cancer. Researchers want to see how well this combination shrinks tumors. You could be eligible if you are 18 or older, have a single, confirmed basal cell carcinoma lesion, and meet certain health criteria. The study will compare three groups: one receiving daily vismodegib and three cycles of SP-002, another receiving daily vismodegib and one cycle of SP-002, and a third receiving only daily vismodegib. The main goal is to measure how many participants' tumors respond to treatment by Week 26. The study is currently recruiting participants.

Study design
This is a Phase 2, open-label, randomized study with three treatment arms, planning to enroll 80 participants. It will be conducted in two parts.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, objective response rate, is measured at Week 26.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06344052

To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Stamford Pharmaceuticals, Inc.
~80 participants
Updated 2024-09-20 on ClinicalTrials.gov
What's tested:SP-002Vismodegib

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate
Measured over Week 26

Conditions

Basal Cell Carcinoma

Explore related trials

Basal Cell Carcinoma

Where it's being run

10 sites across 6 states
Florida3
Texas3
Arizona1
Maryland1
Missouri1
New York1

Study leadership

  • Stamford Pharmaceuticals · STUDY_CHAIR · Stamford Pharmaceuticals

Who to contact

Stamford Pharmaceuticals
[email protected]
5126944241
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.
Achieved objective response with disease progression \>3 months after treatment discontinuation.
Neutrophil count \>1,500/mm3
Hemoglobin \>9 g/dL
Platelet count \>100,000/ mm3
Prothrombin international normalized ratio \<1.5 8. 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 9. Adequate renal function, as defined by the following:
Creatinine \<1.5 x ULN 10. For female subjects 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 \[USPI\]) 24 months after discontinuation of vismodegib.
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 12 months of amenorrhea in the absence of other biological causes. In addition, females under the age of 55 years must have a documented serum follicle stimulating hormone level \>40 mIU/mL to confirm menopause.

Exclusion

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. 2. laBCC that has recurred in the same location after two or more surgical procedures, or that has recurred following radiation therapy. 3. laBCC that has bone involvement (radiologically confirmed if clinically suspected). 4. laBCC with invasion of underlying soft tissue that is not accessible by standard syringe/needle. 5. Patients with evidence of metastatic BCC. 6. Female subjects who are lactating or pregnant. 7. Life expectancy of \<12 weeks. 8. Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, or radiation therapy). 9. Recent (within 4 weeks of Day 1), current, or planned participation in an experimental drug study. 10. 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 of the breast, or carcinoma in situ of the cervix. 11. Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics. 12. 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 drug or that might affect interpretation of the results of the study or renders the subject at high risk from treatment complications.

What this trial measures

  • Objective response rateWeek 26

    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.