Basal Cell CarcinomaPhase 2NCT06344052
To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma
A Phase 2 study testing SP-002 and Vismodegib in people with Basal Cell Carcinoma, run by Stamford Pharmaceuticals, Inc. at 10 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- SP-002 and Vismodegib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 10 sitesUnited States
- Study dates
- 9 Apr 2024to 30 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 at longest diameter, that in the opinion of the investigator:
- is considered not a good candidate for surgery or has recurred after definitive surgical treatment and curative surgical resection is unlikely. OR
- subject has a medical contraindication to surgery where acceptable medical contraindications to surgery include:
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- 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.
- Achieve best response of PR with persistent disease that continues to meet study inclusion criteria 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 discretion of the investigator.
- 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.
- 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.
- 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 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.
- 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.
Who cannot join
- 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).
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- laBCC with invasion of underlying soft tissue that is not accessible by standard syringe/needle.
- Patients with evidence of metastatic BCC.
- Female subjects 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 of the breast, or carcinoma in situ of the cervix.
- 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 drug or that might affect interpretation of the results of the study or renders the subject at high risk from treatment complications.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Research Site
Boca Raton, Florida, 33321
- Recruiting
Research Site
Cedar Park, Texas, 78613
- Recruiting
Research Site
Coral Springs, Florida, 33065
- Recruiting
Research Site
Cutler Bay, Florida, 33157
- Recruiting
Research Site
Humble, Texas, 77346
- Recruiting
Research Site
Lee's Summit, Missouri, 64064
- Recruiting
Research Site
Longview, Texas, 75601
- Recruiting
Research Site
Phoenix, Arizona, 85006
- Recruiting
Research Site
Rochester, New York, 14564
- Recruiting
Research Site
Rockville, Maryland, 20850
About this study
Official title: A Phase 2 Study to Assess the Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma
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.
Read the detailed description
This is a Phase 2, 3-arm, multi-center, open-label, randomized, clinical study to evaluate the efficacy of SP-002 in combination with vismodegib in subjects with locally advanced Basal cell carcinoma.
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
- Basal Cell Carcinoma
- Being tested
- SP-002, Vismodegib
- Keywords
- locally advanced
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP-002Drug
SP-002 is a replication deficient adenovirus-5 encoding human interferon gamma (IFNγ), designed for intra-tumoral administration
VismodegibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | vismodegib, with 3 cycles SP-002 Receives: Drug: SP-002; Drug: Vismodegib |
| Arm 2 | Experimental | vismodegib, with 1 cycles SP-002 Receives: Drug: SP-002; Drug: Vismodegib |
| Arm 3 | Placebo comparator | vismodegib monotherapy Receives: Drug: Vismodegib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
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.
Measured: Week 26
Secondary outcomes (7)
Duration of response
DOR defined as the time interval between the date of first response (CR or PR) of the target lesion to the date of disease progression or death from any cause. Disease progression as assessed by central review.
Measured: Month 36
Progressive free survival
PFS defined as the time interval between the date of randomization/start of treatment to the date of first documented progression of the target tumor or death. If a subject has not had an event, PFS is censored at the date of last adequate tumor assessment. Rate of disease progression of the target tumor as assessed by central review.
Measured: Month 36
Overall survival (OS)
OS defined as the time interval between the date of randomization and the date of death. If a subject has not had an event, the patient will be censored at the date of the last study visit attended.
Measured: Month 36
Objective Response Rate (ORR) / Complete Response (CR) / Partial Response (PR)
ORR/CR/PR by investigator assessment (color photography/imaging [RECIST-measurable]).
Measured: Month 36
Number of subjects discontinuing treatment with SP-002 and/or vismodegib due to toxicity.
Safety of Participants
Measured: Month 36
Number of subjects with delays to SP-002 and/or vismodegib dosing due to toxicity.
Safety of Participants
Measured: Month 36
Incidence and severity of SP-002 and/or vismodegib related AEs.
Safety of Participants
Measured: Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start9 Apr 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stamford Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stamford Pharmaceuticals, Study chair, Stamford Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344052
- Sponsor's protocol ID
- SP-002-004
- Status last verified
- Sep 2024
- First submitted
- 27 Mar 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Assess the Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06344052
- Acronym / sponsor ID
- SP-002-004
- Conditions
- Basal Cell Carcinoma
- Keywords
- locally advanced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Stamford Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 2, 3-arm, multi-center, open-label, randomized, clinical study to evaluate the efficacy of SP-002 in combination with vismodegib in subjects with locally advanced Basal cell carcinoma.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: SP-002, Drug: Vismodegibvismodegib, with 3 cycles SP-002 |
| Arm 2 | Experimental | Drug: SP-002, Drug: Vismodegibvismodegib, with 1 cycles SP-002 |
| Arm 3 | Placebo comparator | Drug: Vismodegibvismodegib monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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 at longest diameter, that in the opinion of the investigator:
- 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:
Key exclusion criteria (15 listed)
- laBCC that has progressed on systemic HHPI therapy as defined below:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SP-002SP-002 is a replication deficient adenovirus-5 encoding human interferon gamma (IFNγ), designed for intra-tumoral administration | Drug | Arm 1, Arm 2 |
| VismodegibThe 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. | Drug | Arm 1, Arm 2, Arm 3 |
Primary outcome
Objective response rate
Time frame: Week 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.
7 secondary outcomes
Duration of response
Time frame: Month 36
Progressive free survival
Time frame: Month 36
Overall survival (OS)
Time frame: Month 36
Objective Response Rate (ORR) / Complete Response (CR) / Partial Response (PR)
Time frame: Month 36
Number of subjects discontinuing treatment with SP-002 and/or vismodegib due to toxicity.
Time frame: Month 36
Number of subjects with delays to SP-002 and/or vismodegib dosing due to toxicity.
Time frame: Month 36
Incidence and severity of SP-002 and/or vismodegib related AEs.
Time frame: Month 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stamford Pharmaceuticals study chair
Stamford Pharmaceuticals
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SP-002 and Vismodegib in people with Basal Cell Carcinoma, run by Stamford Pharmaceuticals, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stamford Pharmaceuticals (5126944241, clinicaltrials@stamfordpharmaceuticals.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.