NCT04844983

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

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intralesional Injection of STP705 in Adult Patients With Cutaneous Squamous Cell Carcinoma in Situ (isSCC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Sirnaomics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a two-part, double-blind, randomized, placebo-controlled study designed to evaluate safety and efficacy of various doses of STP705 administered as an intralesional injection in subjects with isSCC. A total of up to 100 eligible subjects will be enrolled. Enrolled subjects will be randomly allocated to receive STP705 or placebo injection once weekly for 6 weeks. After 6 weeks, the lesion will be excised. In part 1 (dose ranging study): 40 subjects will be randomized to receive 1 of the 3 STP705 doses or placebo. An interim analysis will be done after all subjects have completed end of treatment (EOT) visits to determine 2 selected dose levels of STP705 to be used in part of the study. In part 2: 60 additional subjects will be randomized to receive 1 of the 2 selected doses (from part 1) or placebo. In both parts at the End of Treatment (EOT), the lesion will be excised.

Conditions

• Squamous Cell Carcinoma in Situ

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-05-18
• Primary completion: 2022-08-24
• Completion: 2022-12-06
• First posted: 2021-04-14
• Last updated: 2024-03-18

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study