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A Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Patients With isSCC

NCT04844983

Description:

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 situ) skin cancer (isSCC).

Related Conditions:
  • Skin Squamous Cell Carcinoma In Situ
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Patients With isSCC
  • Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intralesional Injection of STP705 in Adult Patients With Cutaneous Squamous Cell Carcinoma in Situ (isSCC)

Clinical Trial IDs

  • ORG STUDY ID: SRN-705-008
  • NCT ID: NCT04844983

Conditions

  • Squamous Cell Carcinoma in Situ

Interventions

DrugSynonymsArms
STP705Part 1: Arm A

Purpose

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 situ) skin cancer (isSCC).

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 isSCC.

      A total of up to 100 eligible subjects will be enrolled. Enrolled subjects will be randomly
      allocated to receive STP705 or placebo injection once weekly for 6 weeks.

      After 6 weeks, the lesion will be excised.

      In part 1 (dose ranging study): 40 subjects will be randomized to receive 1 of the 3 STP705
      doses or placebo.

      An interim analysis will be done after all subjects have completed end of treatment (EOT)
      visits to determine 2 selected dose levels of STP705 to be used in part of the study.

      In part 2: 60 additional subjects will be randomized to receive 1 of the 2 selected doses
      (from part 1) or placebo.

      In both parts at the End of Treatment (EOT), the lesion will be excised.
    

Trial Arms

NameTypeDescriptionInterventions
Part 1: Arm AExperimentalSTP705 30 μg dose, intralesional injection, given once a week for 6 weeks.
  • STP705
Part 1: Arm BExperimentalSTP705 60 μg dose, intralesional injection, given once a week for 6 weeks.
  • STP705
Part 1: Arm CExperimentalSTP705 90 μg dose, intralesional injection, given once a week for 6 weeks.
  • STP705
Part 1: Arm DOtherPlacebo (normal saline), intralesional injection, given once a week for 6 weeks.
    Part 2: Arm A, B or CExperimentalSTP705 selected dose 1, intralesional injection, given once a week for 6 weeks.
    • STP705
    Part 2: Arm A or B or CExperimentalSTP705 selected dose 2, intralesional injection, given once a week for 6 weeks.
    • STP705
    Part 2: Arm DOtherPlacebo (normal saline), intralesional injection, given once a week for 6 weeks.

      Eligibility Criteria

              Inclusion Criteria:
      
                1. Male or female adult ≥ 18 years of age.
      
                2. 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.
      
                3. Histological diagnosis made no more than 6 months prior to the screening visit.
      
                4. No other dermatological disease in the isSCC target site or surrounding area, which in
                   the opinion of the investigator, could interfere with the study.
      
                5. Willing to refrain from using non-approved lotions or creams on the target site and
                   surrounding area during the treatment period.
      
                6. 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.
      
                7. 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.
      
                8. Ability to follow study instructions and likely to complete all study requirements.
      
                9. Written informed consent obtained, including consent for tissue to be examined and
                   stored by the Central Histology Lab.
      
               10. Written consent to allow photographs of the target isSCC lesion to be used as part of
                   the study data and documentation.
      
               11. 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 Criteria:
      
                1. Pregnant, lactating, or planning to become pregnant.
      
                2. Presence of known or suspected systemic cancer.
      
                3. Histological evidence of severe squamous metaplasia, infiltrative, desmoplastic or
                   micronodular growth patterns in the biopsy specimen.
      
                4. History of recurrence of the target isSCC lesion.
      
                5. Concurrent disease or treatment that suppresses the immune system.
      
                6. Patients with baseline QTC > 480 msec using Frederica's formula.
      
                7. 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.
      
                8. Known sensitivity to any of the ingredients in the study medication including an
                   allergy to trehalose.
      
                9. Use of a tanning bed or other excessive or prolonged exposure to ultraviolet light or
                   direct sunlight during the study.
      
               10. Treatment with systemic chemotherapeutic agents within the 6 months prior to the
                   screening visit.
      
               11. Use of systemic retinoids within the 6 months prior to the screening period.
      
               12. Treatment with systemic immunomodulators or immunosuppressants within the 6 months
                   prior to the screening period.
      
               13. Use of topical immunomodulators within 2 cm of the target isSCC lesion within the 4
                   weeks prior to the screening period.
      
               14. 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.
      
               15. 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.
      
               16. Evidence of current chronic alcohol or drug abuse.
      
               17. Current enrollment in an investigational drug or device study or participation in such
                   a study within 4 weeks of the screening visit.
      
               18. In the investigator's opinion, evidence of unwillingness, or inability to follow the
                   restrictions and requirements of the protocol and complete the study.
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Proportion of participants with histological clearance of treated isSCC lesion
      Time Frame:6 weeks
      Safety Issue:
      Description:Proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT).

      Secondary Outcome Measures

      Measure:Change in size of the treated isSCC lesion
      Time Frame:6 weeks
      Safety Issue:
      Description:Change in size of the treated isSCC lesion over the 6-week treatment period.

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Sirnaomics

      Last Updated

      May 27, 2021