Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04293679 · ClinicalTrials.gov registry record · Phase 1
Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With isSCC
A Phase 1 study of Bowen's Disease and Cutaneous Squamous Cell Carcinoma in Situ, sponsored by Sirnaomics.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT04293679: Completed Phase 1 study of Bowen's Disease and Cutaneous Squamous Cell Carcinoma in Situ, sponsored by Sirnaomics.
NCT04293679 is a Phase 1 study of Bowen's Disease and Cutaneous Squamous Cell Carcinoma in Situ that has completed, run by Sirnaomics. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04293679, a Phase 1 study of Bowen's Disease and Cutaneous Squamous Cell Carcinoma in Situ, has completed, sponsored by Sirnaomics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Proportion of participants with histological clearance of treated isSCC lesion at the End of Treatment (EOT). Histological clearance (HC) will be defined as the absence of detectable evidence of isSCC tumor cell nests as determined by central pathology review.
Conditions Studied
Interventions
- DRUG STP705
Study Locations (1)
Florida
- Center for Clinical and Cosmetic Research - Aventura
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-03-21 |
| Est. Completion | 2020-10-21 |
| Phase | Phase 1 |
What the finished NCT04293679 record still lists
NCT04293679 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 2 conditions, with Bowen's Disease appearing as the primary indexed condition, and to 1 intervention - of which STP705 is the first listed.
NCT04293679 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04293679 about?
NCT04293679 is a clinical study titled "Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With isSCC". 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 d...
What is the current status of trial NCT04293679?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2019-03-21. Estimated completion is 2020-10-21.
What conditions does trial NCT04293679 study?
This clinical trial studies the following conditions: Bowen's Disease, Cutaneous Squamous Cell Carcinoma in Situ.
What interventions are being tested in trial NCT04293679?
The interventions under investigation include: STP705 (DRUG).
Who is sponsoring clinical trial NCT04293679?
This trial is sponsored by Sirnaomics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04293679 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04293679's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01166854 · 25 participants
Characterization of Familial Myopathy and Paget Disease of Bone
- NCT01913106 · 25 participants · Phase 1
HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer
- NCT02138669 · 25 participants · NA
Intacs Prescription Inserts for Keratoconus Patients
- NCT02174549 · 25 participants · Phase 1
Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI