Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With isSCC

NCT04293679 | Completed Phase 1 FDA Drug

• 1 other identifier: SRN-705-004
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, dose escalation study to evaluate the safety and efficacy of intralesional injection of STP705 in adult patients with Cutaneous Squamous Cell Carcinoma in situ (isSCC, Bowen's disease). The purpose of this trial is to evaluate the safety, tolerability and efficacy of various doses of STP705 administered as Intralesional injection in subjects with isSCC. Goals:

• To determine the safe and effective recommended dose of STP705 for the treatment of isSCC.
• Analysis of biomarkers common to isSCC formation pathway including TGF-β1 and COX-2.

Conditions

Bowen's Disease; Cutaneous Squamous Cell Carcinoma in Situ

Keywords

isSCC; Cutaneous Squamous Cell Carcinoma; STP705; Cutaneous Squamous Cell Carcinoma in situ

Outcome Measures

Primary Outcomes (1)

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

  Proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT). Histological clearance (HC) will be defined as the absence of detectable evidence of isSCC tumor cell nests as determined by central pathology review.

  6 weeks

Secondary Outcomes (4)

• Time to histological clearance of treated isSCC lesion over the 6 week treatment period.

  over the 6 week treatment period

• Proportion of participants with complete clinical clearance of treated isSCC lesion based on investigator assessment at the End of Treatment (EOT).

  6 weeks

• Time to complete clinical clearance of treated isSCC lesion based on investigator assessment over the 6 week treatment period.

  over the 6 week treatment period

• Change in size of the treated isSCC lesion over the 6 week treatment period.

  over the 6 week treatment period

Study Arms (5)

Cohort A: STP705 10 μg dose

EXPERIMENTAL

Cohort A: STP705 10 μg dose, intradermal injection, given once a week for up to 6 weeks

Drug: STP705

Cohort B: STP705 20 μg dose

EXPERIMENTAL

Cohort B: STP705 20 μg dose, intradermal injection, given once a week for up to 6 weeks

Drug: STP705

Cohort C: STP705 30 μg dose

EXPERIMENTAL

Cohort C: STP705 30 μg dose, intradermal injection, given once a week for up to 6 weeks

Drug: STP705

Cohort D: STP705 60 μg dose

EXPERIMENTAL

Cohort D: STP705 60 μg dose, intradermal injection, given once a week for up to 6 weeks

Drug: STP705

Cohort E: STP705 120 μg dose

EXPERIMENTAL

Cohort E: STP705 120 μg dose, intradermal injection, given once a week for up to 6 weeks

Drug: STP705

Interventions

STP705 DRUG

Investigational Product

Cohort A: STP705 10 μg dose; Cohort B: STP705 20 μg dose; Cohort C: STP705 30 μg dose; Cohort D: STP705 60 μg dose; Cohort E: STP705 120 μg dose

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-peri-orbital/-anogenital/-facial/-scalp) isSCC lesion suitable for excision with a minimum diameter of 0.5cm and with a maximum diameter of 2.0cm.
• \. Histological diagnosis made no more than 6 months prior to the screening visit.
• \. Histological biopsy removed ≤25% of the original area of the target lesion.
• \. 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 is clinically acceptable to the investigator. Acceptable "out of range" values are generally those within 2 standard deviations of the mean or explainable due to concurrent medications or disease processes.
• \. 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 or lactating.
• \. Presence of known or suspected systemic cancer.
• \. Histological evidence of nBCC, sBCC, invasive SCC, or any other non-isSCC tumor in the biopsy specimen.
• \. Histological evidence of severe squamous metaplasia, infiltrative, desomoplastic or micronodular growth patterns in the biopsy specimen.
• \. History of recurrence of the target isSCC lesion.
• \. Prior exposure to STP705.
• \. Evidence of dermatological disease or confounding skin condition in the treatment area, e.g., BCC, actinic keratosis, rosacea, psoriasis, atopic dermatitis, eczema, xeroderma pigmentosa.
• \. 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.
• \. Use of a tanning beds 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.

Sponsors & Collaborators

• Sirnaomics: lead
• Amarex Clinical Research: collaborator

Study Sites (1)

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

Related Publications (1)

• Kuzbicki L, Brozyna AA. Expression of Cyclooxygenase-2 in Human Epithelial Skin Lesions: A Systematic Review of Immunohistochemical Studies. Appl Immunohistochem Mol Morphol. 2021 Mar 1;29(3):163-174. doi: 10.1097/PAI.0000000000000871.

  PMID: 32889812 DERIVED

MeSH Terms

Conditions

Bowen's Disease

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Study Officials

• Kush Dhody, MBBS, MS, CCRA

  Amarex Clinical Research, LLC (Amarex)

  STUDY DIRECTOR

• Brian Berman, MD, PhD

  Center for Clinical and Cosmetic Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants in the first cohort will attend the study center once weekly for an injection of STP705 into the isSCC lesion. The participants will receive injections of STP705 once a week for up to 6 weeks. The clinician will evaluate the tumor for clinical changes and reduction in size at each treatment visit for up to 6 weeks. If during the 6 weeks of treatment there is Complete Clinical Clearance of the tumor, the treatments will end. At the End of Treatment visit, the residual tumor, or former tumor location, will be excised for analysis. In the absence of dose limiting toxicities (DLT), the subsequent cohorts will receive increasing doses of STP705, following the same schedule of administration as the first cohort.

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 3, 2020
• Study Start: March 21, 2019
• Primary Completion: October 21, 2020
• Study Completion: October 21, 2020
• Last Updated: June 9, 2022

Record last verified: 2020-12

Locations

US (1)