NCT04735978

Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours

An Open-Label, Multicenter, Phase 1 Study of RP3 as a Single Agent and in Combination With PD-1 Blockade in Patients With Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 123 (estimated)
• Sponsor: Replimune, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, multicenter, open label, single agent dose escalation and combination treatment study of RP3 in adult participants with advanced solid tumors, to evaluate the safety and tolerability of RP3 both as a single agent and in combination with anti-PD1 therapy and to determine the recommended Phase 2 dose (RP2D) of RP3.

Detailed description

RP3 is a genetically modified herpes simplex type 1 virus (HSV-1) that expresses exogenous genes (anti-CTLA-4 antibody, CD40 ligand and h4-1BBL) designed to directly destroy tumors and generate an anti-tumor immune response

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	RP3	Genetically modified HSV-1
BIOLOGICAL	Nivolumab	anti-PD1 monoclonal antibody

Timeline

• Start date: 2020-12-29
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2021-02-03
• Last updated: 2026-02-27

Locations

13 sites across 5 countries: United States, France, Greece, Spain, United Kingdom

Regulatory

• FDA-regulated drug study