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

NCT06344052 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: SP-002-004
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 10

Brief 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 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.

Conditions

Basal Cell Carcinoma

Keywords

locally advanced

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 26

Secondary Outcomes (7)

• Duration of response

  Month 36

• Progressive free survival

  Month 36

• Overall survival (OS)

  Month 36

• Objective Response Rate (ORR) / Complete Response (CR) / Partial Response (PR)

  Month 36

• Number of subjects discontinuing treatment with SP-002 and/or vismodegib due to toxicity.

  Month 36

Study Arms (3)

Arm 1

EXPERIMENTAL

vismodegib, with 3 cycles SP-002

Drug: SP-002; Drug: Vismodegib

Arm 2

EXPERIMENTAL

vismodegib, with 1 cycles SP-002

Drug: SP-002; Drug: Vismodegib

Arm 3

PLACEBO COMPARATOR

vismodegib monotherapy

Drug: Vismodegib

Interventions

SP-002 DRUG

SP-002 is a replication deficient adenovirus-5 encoding human interferon gamma (IFNγ), designed for intra-tumoral administration

Arm 1; Arm 2

Vismodegib DRUG

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 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.
• 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:

You may not qualify 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).
• 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.

Sponsors & Collaborators

• Stamford Pharmaceuticals, Inc.: lead

Study Sites (10)

Research Site

Phoenix, Arizona, 85006, United States

RECRUITING

Research Site

Boca Raton, Florida, 33321, United States

RECRUITING

Research Site

Coral Springs, Florida, 33065, United States

RECRUITING

Research Site

Cutler Bay, Florida, 33157, United States

RECRUITING

Research Site

Rockville, Maryland, 20850, United States

RECRUITING

Research Site

Lee's Summit, Missouri, 64064, United States

RECRUITING

Research Site

Rochester, New York, 14564, United States

RECRUITING

Research Site

Cedar Park, Texas, 78613, United States

RECRUITING

Research Site

Humble, Texas, 77346, United States

RECRUITING

Research Site

Longview, Texas, 75601, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

HhAntag691

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Officials

• Stamford Pharmaceuticals

  Stamford Pharmaceuticals

  STUDY CHAIR

Central Study Contacts

Stamford Pharmaceuticals

CONTACT

5126944241; clinicaltrials@stamfordpharmaceuticals.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 3, 2024
• Study Start: April 9, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 30, 2029
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)