Study on the Safety and Effectiveness of SP-002 with Vismodegib for Treating Locally Advanced Basal Cell Carcinoma

Sponsor: Stamford Pharmaceuticals, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06344052

Provider View

This clinical trial is testing a new treatment using SP-002 along with vismodegib to see if it can help control locally advanced basal cell carcinoma, a type of skin cancer. The study will compare different treatment plans to find out which works best.

Patient Parameters

Program Overview

The purpose of this study is to find out how well the new drug SP-002 works when used with vismodegib in treating locally advanced basal cell carcinoma (BCC). Researchers want to know how many patients see their tumors shrink after 1 or 3 cycles of SP-002, in addition to their regular treatment with a hedgehog pathway inhibitor. Participants will be divided into three groups: one group will receive daily hedgehog pathway inhibitor and 3 cycles of SP-002, another group will receive daily hedgehog pathway inhibitor and 1 cycle of SP-002, and the last group will receive only the daily hedgehog pathway inhibitor.

Description

This study is a Phase 2 trial with three groups, conducted at multiple centers, to test the effectiveness of SP-002 combined with vismodegib in patients with locally advanced basal cell carcinoma. The study will be done in two parts, each including a screening, treatment, and follow-up period.

  • Part A: 20 participants will be randomly assigned to two groups (Arm 2 and Arm 3) to gather initial safety and performance data.
  • Part B: 60 participants will be randomly assigned to three groups (Arm 1, Arm 2, and Arm 3) to further evaluate the treatment's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Must be 18 years or older.
  • Must have a performance status score of 0, 1, or 2, indicating good overall health.
  • Must have a single basal cell carcinoma lesion that is at least 1 cm in size and not a good candidate for surgery, or has returned after surgery, or surgery is not an option due to medical reasons.
  • Radiation therapy must not be suitable due to reasons like genetic conditions or tumor location.
  • Must be willing to follow all study requirements, including biopsies.
  • Must have adequate blood cell counts and liver and kidney function.
  • Women of childbearing potential must agree to use two forms of birth control during and after the study.
  • Must agree not to donate blood or sperm during and after the study.

Exclusion Criteria

  • Basal cell carcinoma that has worsened on hedgehog pathway inhibitor therapy.
  • Cancer that has returned in the same spot after multiple surgeries or radiation.
  • Cancer that has spread to the bones or other areas not easily accessible.
  • Evidence of metastatic basal cell carcinoma.
  • Women who are pregnant or breastfeeding.
  • Life expectancy of less than 12 weeks.
  • Currently receiving other cancer treatments not specified in the study.
  • Participation in another drug study within 4 weeks.
  • History of other cancers within the last 3 years, except for certain low-risk types.
  • Uncontrolled medical conditions that could interfere with the study.

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