Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344052
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-03-27
Brief Title:
To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma
Sponsor:
Stamford Pharmaceuticals Inc
Organization:
Stamford Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 2 Study to Assess the Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 11 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 111 ratio into 3 treatment arms Arm 1 Arm 2 and Arm 3 in a population with target Basal cell carcinoma lesions
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 11 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 111 ratio into 3 treatment arms Arm 1 Arm 2 and Arm 3 in a population with target Basal cell carcinoma lesions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None