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

NCT04844983 | Completed Phase 2 FDA Drug

• 1 other identifier: SRN-705-008
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 7

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).

Conditions

Squamous Cell Carcinoma in Situ

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with histological clearance of treated isSCC lesion

  Proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT).

  6 weeks

Secondary Outcomes (1)

• Change in size of the treated isSCC lesion

  6 weeks

Study Arms (7)

Part 1: Arm A

EXPERIMENTAL

STP705 30 μg dose, intralesional injection, given once a week for 6 weeks.

Drug: STP705

Part 1: Arm B

EXPERIMENTAL

STP705 60 μg dose, intralesional injection, given once a week for 6 weeks.

Drug: STP705

Part 1: Arm C

EXPERIMENTAL

STP705 90 μg dose, intralesional injection, given once a week for 6 weeks.

Drug: STP705

Part 1: Arm D

OTHER

Placebo (normal saline), intralesional injection, given once a week for 6 weeks.

Other: Placebo Saline

Part 2: Arm A, B or C

EXPERIMENTAL

STP705 selected dose 1, intralesional injection, given once a week for 6 weeks.

Drug: STP705

Part 2: Arm A or B or C

EXPERIMENTAL

STP705 selected dose 2, intralesional injection, given once a week for 6 weeks.

Drug: STP705

Part 2: Arm D

OTHER

Placebo (normal saline), intralesional injection, given once a week for 6 weeks.

Other: Placebo Saline

Interventions

STP705 DRUG

The STP705 drug substance is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively.

Also known as: STP705 Powder for Injection

Part 1: Arm A; Part 1: Arm B; Part 1: Arm C; Part 2: Arm A or B or C; Part 2: Arm A, B or C

Placebo Saline OTHER

Normal Saline

Part 1: Arm D; Part 2: Arm D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sirnaomics: lead

Study Sites (7)

Investigate MD

Scottsdale, Arizona, 85255, United States

Location

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

Research Institute of the Southeast LLC

West Palm Beach, Florida, 33401, United States

Location

Dermatology, Laser and Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

Location

Dermatology Associates of Knoxville

Knoxville, Tennessee, 37909, United States

Location

Tennessee Clinical Research

Nashville, Tennessee, 37215, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

MeSH Terms

Conditions

Squamous Intraepithelial Lesions

Interventions

Injections

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mark Nestor, MD

  Center for Clinical and Cosmetic Research

  PRINCIPAL INVESTIGATOR

• David Goldberg

  Schweiger Dermatology Group

  PRINCIPAL INVESTIGATOR

• Michael Gold, MD

  Tennessee Clinical Research

  PRINCIPAL INVESTIGATOR

• Edward Lain, MD

  Austin Institute for Clinical Research

  PRINCIPAL INVESTIGATOR

• Kenneth Beer, MD

  Research Institute of the Southeast LLC

  PRINCIPAL INVESTIGATOR

• Brenda LaTowsky, MD

  Investigate MD

  PRINCIPAL INVESTIGATOR

• Edward Primka, MD

  Dermatology Associates of Knoxville

  PRINCIPAL INVESTIGATOR

• Girish Munavalli, MD

  Dermatology, Laser and Vein Specialists of the Carolinas

  PRINCIPAL INVESTIGATOR

• Brian Jiang, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Megan Couvillion, MD

  SBA Dermatology

  PRINCIPAL INVESTIGATOR

• Mark Ling, MD

  Medaphase Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study. All subjects, investigators, and site staff (except unblinded pharmacist or designated site staff) in the study will be blinded to the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 14, 2021
• Study Start: May 18, 2021
• Primary Completion: August 24, 2022
• Study Completion: December 6, 2022
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)