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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Stamford Pharmaceuticals, Inc.
Study ID
NCT06344052
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 9, 2024
Status verified
Sep 2024
Primary completion
Sep 30, 2026
Completion
Mar 30, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    vismodegib, with 3 cycles SP-002
  • Experimental: Arm 2
    vismodegib, with 1 cycles SP-002
  • Placebo Comparator: Arm 3
    vismodegib monotherapy

Primary Outcome Measure

Objective response rate [ Time Frame: Week 26 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Research SitePhoenixArizona85006-
Research SiteBoca RatonFlorida33321-
Research SiteCoral SpringsFlorida33065-
Research SiteCutler BayFlorida33157-
Research SiteRockvilleMaryland20850-
Research SiteLee's SummitMissouri64064-
Research SiteRochesterNew York14564-
Research SiteCedar ParkTexas78613-
Research SiteHumbleTexas77346-
Research SiteLongviewTexas75601-

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