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

NCT04669808 | Completed Phase 2 FDA Drug

• 1 other identifier: SRN-705-006
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 2, open label, dose escalation study is designed to evaluate the safety, tolerability and efficacy of various doses of STP705 administered as localized injection in patients with Basal Cell Carcinoma (BCC). Goals:

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

Conditions

Basal Cell Carcinoma

Keywords

BCC; STP705; Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with histological clearance of treated basal cell carcinoma lesion at the End of Treatment (EOT)

  Histological clearance (HC) will be defined as the absence of detectable evidence of BCC tumor cell nests as determined by central pathology review.

  6 weeks

Secondary Outcomes (1)

• Change in clinical diameter of the treated basal cell carcinoma lesion over the 6 week treatment period

  over the 6 week treatment period

Study Arms (7)

Cohort A: STP705 30 μg dose

EXPERIMENTAL

Cohort A: STP705 30 μg dose, localized injection, given once a week for 6 weeks

Drug: STP705

Cohort B: STP705 60 μg dose

EXPERIMENTAL

Cohort B: STP705 60 μg dose, localized injection, given once a week for 6 weeks

Drug: STP705

Cohort C: STP705 90 μg dose

EXPERIMENTAL

Cohort C: STP705 90 μg dose, localized injection, given once a week for 6 weeks

Drug: STP705

Cohort D: STP705 120 μg dose

EXPERIMENTAL

Cohort D: STP705 120 μg dose, localized injection, given once a week for 6 weeks

Drug: STP705

Cohort E: STP705 180 μg dose

EXPERIMENTAL

Cohort E: STP705 180 μg dose, localized injection, given once a week for 6 weeks

Drug: STP705

Cohort F: STP705 240 μg dose

EXPERIMENTAL

Cohort F: STP705 240 μg dose, localized injection, given once a week for 6 weeks

Drug: STP705

Cohort G: STP705 320 μg dose

EXPERIMENTAL

Cohort G: STP705 320 μg dose, localized injection, given once a week for 6 weeks

Drug: STP705

Interventions

STP705 DRUG

Dry powder for intra-and peri-lesional injection.

Also known as: STP705 Powder for Injection

Cohort A: STP705 30 μg dose; Cohort B: STP705 60 μg dose; Cohort C: STP705 90 μg dose; Cohort D: STP705 120 μg dose; Cohort E: STP705 180 μg dose; Cohort F: STP705 240 μg dose; Cohort G: STP705 320 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) basal cell carcinoma 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.
• Histological biopsy removed ≤25% of the original volume of the target lesion.
• No other dermatological disease in the BCC 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. 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 BCC 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 SCC, or any other non-BCC tumor in the biopsy specimen.
• Histological evidence of infiltrative or other aggressive histological subtype growth patterns in the biopsy specimen.
• History of recurrence of the target BCC lesion.
• Evidence of dermatological disease or confounding skin condition with in 2 cm margin of the target BCC lesion, e.g., SCC, 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.
• Use of topical immunomodulators within 2 cm of the target BCC lesion within the 4 weeks 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

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mark Nestor, MD, PhD

  Center for Clinical and Cosmetic Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON 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 BCC lesion. The participants will receive injections of STP705 once a week for 6 weeks. The clinician will evaluate the change in tumor size at each treatment visit. 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: December 9, 2020
• First Posted: December 17, 2020
• Study Start: December 28, 2020
• Primary Completion: February 9, 2023
• Study Completion: February 9, 2023
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)