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

NCT04844983 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-03-18

No results posted yet for this study

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

Interventions

DRUG

STP705

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

OTHER

Placebo Saline

Normal Saline

Sponsors & Collaborators

  • Sirnaomics

    lead INDUSTRY

Principal Investigators

  • Mark Nestor, MD · Center for Clinical and Cosmetic Research

  • David Goldberg · Schweiger Dermatology Group

  • Michael Gold, MD · Tennessee Clinical Research

  • Edward Lain, MD · Austin Institute for Clinical Research

  • Kenneth Beer, MD · Research Institute of the Southeast LLC

  • Brenda LaTowsky, MD · Investigate MD

  • Edward Primka, MD · Dermatology Associates of Knoxville

  • Girish Munavalli, MD · Dermatology, Laser and Vein Specialists of the Carolinas

  • Brian Jiang, MD · University of California, San Diego

  • Megan Couvillion, MD · SBA Dermatology

  • Mark Ling, MD · Medaphase Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-18
Primary Completion
2022-08-24
Completion
2022-12-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04844983 on ClinicalTrials.gov