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Neo-adjuvant Treatment for Squamous Cell Carcinoma Using Direct Tumor Injection With RP1.

NCT05858229 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-12-31

No results posted yet for this study

Summary

This is a Phase 1b, single-center, open-label study, evaluating efficacy and safety of RP1 for the treatment of resectable cutaneous Squamous Cell Carcinoma in up to 12 evaluable patients. In this study, patients will receive RP1 via direct intratumoral (IT) injection into superficial cutaneous solid tumors to assess the safety and tolerability as well efficacy of RP1 treatment. The primary efficacy population is up to 12 evaluable patients with resectable CSCC. The enrollment of patients with CSCC will determine study duration.

Conditions

Interventions

DRUG

RP1

Recombinant Herpes Simplex Virus Type 1 - hGM CSF/GALV-GP-R-

Sponsors & Collaborators

  • Sherrif Ibrahim

    lead OTHER

Principal Investigators

  • Catherine VanHooft, HT · Rochester Dermatologic Surgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-16
Primary Completion
2025-12-31
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05858229 on ClinicalTrials.gov