To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma
NCT ID: NCT06344052
Last Updated: 2024-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2024-04-09
2029-03-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) in Patients With Advanced Basal Cell Carcinoma
NCT00833417
A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas
NCT01815840
A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma
NCT01898598
Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System
NCT07042295
Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Adults With Facial isSCC
NCT05421013
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study will be completed in 2 consecutive parts. Each part consists of a screening period, a treatment period, and a follow-up period.
* Part A: 20 participants who meet study entry criteria will be randomized in a 1:1 ratio into 2 treatment arms (Arm 2 and Arm 3) and will provide preliminary safety and performance in a population with target Basal cell carcinoma lesions.
* Part B: 60 participants who meet study entry criteria will be randomized in a 1:1:1 ratio into 3 treatment arms (Arm 1, Arm 2, and Arm 3) in a population with target Basal cell carcinoma lesions.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1
vismodegib, with 3 cycles SP-002
SP-002
SP-002 is a replication deficient adenovirus-5 encoding human interferon gamma (IFNγ), designed for intra-tumoral administration
Vismodegib
The HHPI vismodegib is currently indicated for the treatment of adult patients with metastatic BCC, or with laBCC where surgery and/or radiation therapy are not appropriate.
Arm 2
vismodegib, with 1 cycles SP-002
SP-002
SP-002 is a replication deficient adenovirus-5 encoding human interferon gamma (IFNγ), designed for intra-tumoral administration
Vismodegib
The HHPI vismodegib is currently indicated for the treatment of adult patients with metastatic BCC, or with laBCC where surgery and/or radiation therapy are not appropriate.
Arm 3
vismodegib monotherapy
Vismodegib
The HHPI vismodegib is currently indicated for the treatment of adult patients with metastatic BCC, or with laBCC where surgery and/or radiation therapy are not appropriate.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SP-002
SP-002 is a replication deficient adenovirus-5 encoding human interferon gamma (IFNγ), designed for intra-tumoral administration
Vismodegib
The HHPI vismodegib is currently indicated for the treatment of adult patients with metastatic BCC, or with laBCC where surgery and/or radiation therapy are not appropriate.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subject is 18 years of age or older.
3. Eastern Cooperative Oncology Group performance status 0, 1 or 2.
4. 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 at longest diameter, that in the opinion of the investigator:
A. is considered not a good candidate for surgery or has recurred after definitive surgical treatment and curative surgical resection is unlikely. OR
B. subject has a medical contraindication to surgery where acceptable medical contraindications to surgery include:
* 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 of or ongoing HPPI treatment are eligible under the following conditions:
* Achieved objective response with disease progression \>3 months after treatment discontinuation.
Note: where the subject has \>1 lesion, one lesion may be selected for treatment at the discretion of the investigator.
5. 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, or anticipated significant morbidity, loss of function, or unacceptable cosmetic outcomes. Patients with Basal Cell Nevus Syndrome (Gorlin syndrome) may enroll in this study but must meet the criteria for locally advanced or listed above.
6. 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 1-12 weeks before Day 1.
7. 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
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.
For male subjects with female partners of childbearing potential\*, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for at least (per USPI) 24 months after discontinuation of vismodegib.
11. Subjects agree not to donate blood or blood products during the study and for at least (per USPI) 24 months after discontinuation of vismodegib; male subjects agree not to donate sperm during the study and for at least 2 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stamford Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stamford Pharmaceuticals
Role: STUDY_CHAIR
Stamford Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Phoenix, Arizona, United States
Research Site
Boca Raton, Florida, United States
Research Site
Coral Springs, Florida, United States
Research Site
Cutler Bay, Florida, United States
Research Site
Rockville, Maryland, United States
Research Site
Lee's Summit, Missouri, United States
Research Site
Rochester, New York, United States
Research Site
Cedar Park, Texas, United States
Research Site
Humble, Texas, United States
Research Site
Longview, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SP-002-004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.