Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-29 @ 1:35 PM
Study NCT ID:
NCT04669808
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2020-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With Basal Cell Carcinoma
Sponsor:
Sirnaomics
Organization:
Study Overview
Official Title:
An Open Label, Dose Escalation Study to Evaluate the Safety and Efficacy of Localized Injection of STP705 in Adult Patients With Basal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
Basal cell carcinoma occurs most often on areas of the skin that are exposed to the sun, such as head and neck. The most commonly found clinical feature of Basal Cell Carcinoma (BCC) is an elevated tumor with a pearly and translucent margin and telangiectasia. The color may vary widely from nearly normal skin color to erythematous to violaceous and may also be pigmented. BCC may also resemble noncancerous skin conditions such as eczema or psoriasis. The majority of these cancers occur on areas of skin that are regularly exposed to sunlight or other ultraviolet radiation.
The STP705 drug substance (STP705) is composed of two siRNA oligonucleotides, targeting the expression of TGF-β1 and Cox-2 mRNA respectively. Along with the HKP-enhanced delivery system, the combination is expected to downregulate TGF-β1 and COX-2 expression resulting in the inhibition of tumor growth and provide an alternative non-invasive approach for the treatment of BCC.
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 BCC. This study seeks to establish a safe and effective recommended dose of STP705 for the treatment of BCC. 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. Expression of biomarkers common to the BCC formation pathway, including TGF-β1 and COX-2, will be evaluated.
Safety and tolerability will be assessed by the number of incidence of adverse events (AEs) and serious adverse events (SAEs); the incidence of AEs and SAEs leading to discontinuation of trial medication; the incidence and severity of Local Skin Response (LSR); hypopigmentation and hyperpigmentation following treatment; and the tolerability of repeated localized administration of STP705 as assessed by investigator-evaluation of injection site reactions for all patients and within each cohort.
The study plans to enroll approximately 35 adult patients at up to 3 clinical sites in the United States. The 35 patients will be divided equally among 7 cohorts (30, 60, 90, 120, 180, 240, and 320 μg dose level) of 5 patients each.
The STP705 drug substance (STP705) is composed of two siRNA oligonucleotides, targeting the expression of TGF-β1 and Cox-2 mRNA respectively. Along with the HKP-enhanced delivery system, the combination is expected to downregulate TGF-β1 and COX-2 expression resulting in the inhibition of tumor growth and provide an alternative non-invasive approach for the treatment of BCC.
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 BCC. This study seeks to establish a safe and effective recommended dose of STP705 for the treatment of BCC. 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. Expression of biomarkers common to the BCC formation pathway, including TGF-β1 and COX-2, will be evaluated.
Safety and tolerability will be assessed by the number of incidence of adverse events (AEs) and serious adverse events (SAEs); the incidence of AEs and SAEs leading to discontinuation of trial medication; the incidence and severity of Local Skin Response (LSR); hypopigmentation and hyperpigmentation following treatment; and the tolerability of repeated localized administration of STP705 as assessed by investigator-evaluation of injection site reactions for all patients and within each cohort.
The study plans to enroll approximately 35 adult patients at up to 3 clinical sites in the United States. The 35 patients will be divided equally among 7 cohorts (30, 60, 90, 120, 180, 240, and 320 μg dose level) of 5 patients each.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: