Clinical trial NCT04844983: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Squamous Cell Carcinoma in Situ
Lead sponsor: Sirnaomics
Sponsor class: INDUSTRY
First posted: 2021-04-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part 1: 40 subjects randomized in a 1:1:1:1 ratio to receive 6 weeks of treatment of placebo, 30 ug, 60 ug, or 90 ug of STP705. Enrollment will be temporarily stopped after the 40th subject. Interim Analysis will be done for dose response assessment and selection of the 2 doses for Part 2 of the study.

Part 2: 60 additional subjects will be randomized in a 1:1:1 ratio to receive placebo or one of the 2 selected STP705 doses.
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: Proportion of participants with histological clearance of treated isSCC lesion
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in size of the treated isSCC lesion
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Investigate MD
state: Arizona
city: Aventura
country: United States
facility: Center for Clinical and Cosmetic Research
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast LLC
state: Florida
city: Charlotte
country: United States
facility: Dermatology, Laser and Vein Specialists of the Carolinas
state: North Carolina
city: Knoxville
country: United States
facility: Dermatology Associates of Knoxville
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research
state: Tennessee
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
Study officials:
affiliation: Center for Clinical and Cosmetic Research
name: Mark Nestor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Schweiger Dermatology Group
name: David Goldberg
role: PRINCIPAL_INVESTIGATOR
affiliation: Tennessee Clinical Research
name: Michael Gold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Austin Institute for Clinical Research
name: Edward Lain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute of the Southeast LLC
name: Kenneth Beer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Investigate MD
name: Brenda LaTowsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Associates of Knoxville
name: Edward Primka, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology, Laser and Vein Specialists of the Carolinas
name: Girish Munavalli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Brian Jiang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SBA Dermatology
name: Megan Couvillion, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medaphase Inc
name: Mark Ling, MD
role: PRINCIPAL_INVESTIGATOR
References: