NCT04349436

Study to Investigate the Efficacy and Safety of RP1 in Adult Patients With Organ Transplants and Advanced Skin Malignancies

An Open-Label, Multicenter, Phase 1B/2 Study of RP1 in Solid Organ and Hematopoietic Cell Transplant Recipients With Advanced Cutaneous Malignancies (ARTACUS)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Replimune, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of RP1 (administered into the tumor) in 90 patients who have received an organ transplant in the past and currently have skin cancer. The skin cancer is either locally advanced (large tumors in the skin, muscles or nerves) or metastatic (spread to other parts of the body). This study will consist of a 28-day Screening Period, a Treatment Period, and a Follow-up Period. During the Treatment Period, patients will be dosed with RP1 every two weeks for up to 2 years (104 weeks). Tumor measurements will be done approximately every 8 weeks (and additionally if needed) until progressive disease, start of subsequent anticancer therapy, or completion/discontinuation of the study. During the Follow-up Period, patients will visit the clinic at 30, 60, and 100-150 days after their last dose of RP1 for safety and quality of life assessments. Patients will continue follow-up for up to 3 years from the day of the last patient's first dose.

Detailed description

RP1 is a genetically modified herpes simplex type 1 virus that is designed to directly destroy tumors and to generate an anti-tumor immune response. This is a Phase 1B/2, open label, multicenter, study evaluating the objective response rate and the safety and tolerability of RP1 in adult hepatic, renal, heart, lung, other solid organs, and/or hematopoietic cell transplant recipients who subsequently experienced advanced or metastatic cutaneous malignancies. Patients will be dosed with RP1 by direct or ultrasound guided intra-tumoral injection into superficial, subcutaneous, or nodal tumors. No transplanted organs will be injected.

Conditions

• Merkel Cell Carcinoma
• Basal Cell Carcinoma
• Locally Advanced Cutaneous Squamous Cell Carcinoma
• Cancer

Interventions

Type	Name	Description
BIOLOGICAL	RP1, intra-tumoral injection, oncolytic virus	Genetically modified herpes simplex type 1 virus

Timeline

• Start date: 2020-05-15
• Primary completion: 2029-07-01
• Completion: 2029-11-01
• First posted: 2020-04-16
• Last updated: 2026-02-27

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated drug study