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

ClinicalTrials.gov ID: NCT06344052

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Official title

A Phase 2 Study to Assess the Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06344052
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Stamford Pharmaceuticals, Inc.; Industry
Enrollment: 80 participants

Conditions and interventions

Conditions

Basal Cell Carcinoma

Interventions

SP-002 Drug
Vismodegib Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 9, 2024 (Actual)
Primary completion: Sep 30, 2026 (Estimated)
Completion: Mar 30, 2029 (Estimated)
Last update posted: Sep 20, 2024

2024 – 2029

United States locations

U.S. sites: 10
U.S. states: 6
U.S. cities: 10

Facility	City	State	ZIP	Site status
Research Site	Phoenix	Arizona	85006	Recruiting
Research Site	Boca Raton	Florida	33321	Recruiting
Research Site	Coral Springs	Florida	33065	Recruiting
Research Site	Cutler Bay	Florida	33157	Recruiting
Research Site	Rockville	Maryland	20850	Recruiting
Research Site	Lee's Summit	Missouri	64064	Recruiting
Research Site	Rochester	New York	14564	Recruiting
Research Site	Cedar Park	Texas	78613	Recruiting
Research Site	Humble	Texas	77346	Recruiting
Research Site	Longview	Texas	75601	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06344052, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 20, 2024 · Synced Nov 15, 2026