Status:
COMPLETED
A Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Patients With isSCC
Lead Sponsor:
Sirnaomics
Conditions:
Squamous Cell Carcinoma in Situ
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this trial is to evaluate safety, tolerability and efficacy of various doses of STP705 administered as intralesional injection in subjects with cutaneous squamous cell carcinoma (in sit...
Detailed Description
This is a two-part, double-blind, randomized, placebo-controlled study designed to evaluate safety and efficacy of various doses of STP705 administered as an intralesional injection in subjects with i...
Eligibility Criteria
Inclusion
- Male or female adult ≥ 18 years of age.
- Primary, histologically confirmed trunk or extremity (non- anogenital/-facial/-scalp) isSCC lesion suitable for excision with a minimum diameter of 0.5 cm and with a maximum diameter of 2.0 cm.
- Histological diagnosis made no more than 6 months prior to the screening visit.
- No other dermatological disease in the isSCC target site or surrounding area, which in the opinion of the investigator, could interfere with the study.
- Willing to refrain from using non-approved lotions or creams on the target site and surrounding area during the treatment period.
- Willing to refrain from exposure to excessive direct sunlight or ultraviolet light and to avoid the use of tanning parlors for the duration of the study.
- Laboratory values for the tests (listed in the Study Schedule) within the reference ranges as defined by the central laboratory, or "out of range" test results that are clinically acceptable to the investigator.
- Ability to follow study instructions and likely to complete all study requirements.
- Written informed consent obtained, including consent for tissue to be examined and stored by the Central Histology Lab.
- Written consent to allow photographs of the target isSCC lesion to be used as part of the study data and documentation.
- For females of childbearing potential, a negative pregnancy test at screening and using an acceptable form of birth control (oral / implant/ injectable/ transdermal contraceptives, intrauterine device, condom, diaphragm, abstinence, or a monogamous relationship with a partner who has had a vasectomy).
Exclusion
- Pregnant, lactating, or planning to become pregnant.
- Presence of known or suspected systemic cancer.
- Histological evidence of severe squamous metaplasia, infiltrative, desmoplastic or micronodular growth patterns in the biopsy specimen.
- History of recurrence of the target isSCC lesion.
- Concurrent disease or treatment that suppresses the immune system.
- Patients with baseline QTC \> 480 msec using Frederica's formula.
- Chronic medical condition that in the judgment of the investigator(s) would interfere with the performance of the study or would place the patient at undue risk.
- Known sensitivity to any of the ingredients in the study medication including an allergy to trehalose.
- Use of a tanning bed or other excessive or prolonged exposure to ultraviolet light or direct sunlight during the study.
- Treatment with systemic chemotherapeutic agents within the 6 months prior to the screening visit.
- Use of systemic retinoids within the 6 months prior to the screening period.
- Treatment with systemic immunomodulators or immunosuppressants within the 6 months prior to the screening period.
- Use of topical immunomodulators within 2 cm of the target isSCC lesion within the 4 weeks prior to the screening period.
- Treatment with the following topical agents within 2 cm of the target isSCC lesion within the 4 weeks prior to the screening visit: aminolevulinic acid, 5-fluorouracil, corticosteroids, retinoids, diclofenac, ingenol mebutate, or imiquimod.
- Treatment with liquid nitrogen, surgical excision or curettage within 2 cm of the target isSCC lesion during the 4 weeks prior to the screening visit.
- Evidence of current chronic alcohol or drug abuse.
- Current enrollment in an investigational drug or device study or participation in such a study within 4 weeks of the screening visit.
- In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions and requirements of the protocol and complete the study.
Key Trial Info
Start Date :
May 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2022
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04844983
Start Date
May 18 2021
End Date
December 6 2022
Last Update
March 18 2024
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigate MD
Scottsdale, Arizona, United States, 85255
2
Center for Clinical and Cosmetic Research
Aventura, Florida, United States, 33180
3
Research Institute of the Southeast LLC
West Palm Beach, Florida, United States, 33401
4
Dermatology, Laser and Vein Specialists of the Carolinas
Charlotte, North Carolina, United States, 28207