MedTrace Logo

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

NCT04293679 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-06-09

No results posted yet for this study

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

Interventions

DRUG

STP705

Investigational Product

Sponsors & Collaborators

  • Amarex Clinical Research

    collaborator OTHER

  • Sirnaomics

    lead INDUSTRY

Principal Investigators

  • Kush Dhody, MBBS, MS, CCRA · Amarex Clinical Research, LLC (Amarex)

  • Brian Berman, MD, PhD · Center for Clinical and Cosmetic Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-21
Primary Completion
2020-10-21
Completion
2020-10-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04293679 on ClinicalTrials.gov