Study to Evaluate Safety, Efficacy of Intralesional Injection of STP705 in Adults With Facial isSCC

NCT05421013 | Completed Phase 1 FDA Drug

• 1 other identifier: SRN-705-011
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Open label, dose escalation to evaluate safety.

Conditions

Facial isSCC

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with histological clerance of treated isSCC lesion at the end of treatment

  Histological clearance will be defined as the absence of detectable evidence of isSCC tumor cell nests determined by pathology review

  21 weeks

Secondary Outcomes (1)

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  21 weeks

Study Arms (3)

STP705 30ug

EXPERIMENTAL

STP705 will be administered once weekly for 6 weeks

Drug: STP705

STP705 60ug

EXPERIMENTAL

STP705 will be administered once weekly for 6 weeks

Drug: STP705

STP705 90ug

EXPERIMENTAL

STP705 will be administered once weekly for 6 weeks

Drug: STP705

Interventions

STP705 DRUG

STP705 targets TGFB-1 and COX-2 mRNA respectively.

Also known as: STP705 Powder for Injection

STP705 30ug; STP705 60ug; STP705 90ug

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 facial isSCC lesion suitable for excision with a minimum diameter of 0.5 cm and with a maximum diameter of 2.0 cm.
• Histological diagnosis of a qualified isSCC skin lesion (evidenced by a confirmatory histopathology report) made no more than 6 months prior to the screening visit.
• No other dermatological disease in the isSCC target lesion 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 lesion and surrounding area during the treatment period (sunscreen and moisturizers allowed).
• 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 local 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 female subjects of childbearing potential, a negative pregnancy test at screening and using an acceptable form of birth control (oral / implantable / injectable / transdermal contraceptives, intrauterine device, condom, diaphragm, abstinence, or a monogamous relationship with a partner who has had a vasectomy at least 6 months prior to screening).

You may not qualify if:

• Pregnant, lactating, or planning to become pregnant.
• Presence of known or suspected systemic cancer.
• Confirmatory histological report of the qualified isSCC lesion reveals evidence of severe squamous metaplasia, infiltrative, desmoplastic or micronodular growth patterns in the opinion of the investigator.
• History of recurrence of the target isSCC lesion.
• Concurrent disease or treatment that suppresses the immune system.
• Subjects with baseline QT corrected interval QTc \> 480 msec using Fridericia'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, tirbanibulin, 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 (1)

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mark Nestor, MD

  Center for Clinical and Cosmetic Research

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 3 cohorts. In the absence of DLT, subsequent cohorts will receive increasing dose of STP705

Study Record Dates

• First Submitted: June 12, 2022
• First Posted: June 16, 2022
• Study Start: August 1, 2022
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

US (1)