Trials / Active Not Recruiting
Active Not RecruitingNCT05858229
Neo-adjuvant Treatment for Squamous Cell Carcinoma Using Direct Tumor Injection With RP1.
A Phase 1B Study of Intralesional Injection of RP1 in Patients With Resectable Cutaneous SCC
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- Sponsor
- Sherrif Ibrahim · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | RP1 | Recombinant Herpes Simplex Virus Type 1 - hGM CSF/GALV-GP-R- |
Timeline
- Start date
- 2023-06-16
- Primary completion
- 2025-12-01
- Completion
- 2026-06-01
- First posted
- 2023-05-15
- Last updated
- 2025-12-31
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05858229. Inclusion in this directory is not an endorsement.