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

Running, not enrolling · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

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.

Key facts

Study ID

NCT04735978

Run by

Replimune, Inc.

People needed

123

Starts

2020-12-29

Expected to finish

2026-11-30

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with advanced or metastatic non-neurological solid tumors, who have progressed on standard therapy or cannot tolerate standard therapy, or for whom there is no standard therapy preferred to enrollment in a clinical study
• All patients must consent to provide archival tumor biopsy samples within 12 months, or a fresh tumor biopsy is needed. Patients must also consent to provide on treatment biopsies as per protocol
• At least one measurable tumor ≥ 1 cm in longest diameter (or shortest diameter for lymph nodes)
• At least one injectable tumor ≥ 1 cm in longest diameter or injectable tumors which in aggregate are ≥ 1 cm in longest diameter (or shortest diameter for lymph nodes
• Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Note: Predefined inclusion criteria may apply for each additional expansion cohort.

You may not qualify if…

• Prior treatment with an oncolytic virus therapy
• History of viral infections according to the protocol
• Systemic infection requiring intravenous (IV) antibiotics
• Active significant herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis)
• Requires intermittent or chronic use of systemic antivirals
• a. Hepatocellular carcinoma patients with a diagnosis of hepatitis B must be off antiviral therapy for at least 4 weeks prior to enrollment . Hepatocellular carcinoma patients with a history of or ongoing hepatitis C infection must have completed treatment for hepatitis C at least 1 month prior to study enrollment and hepatitis
• History of interstitial lung disease
• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
• Additional Exclusion Criteria for Patients Enrolled in Part 2 (Expansion Cohorts):
• History of life-threatening toxicity related to prior immune treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
• Treatment with botanical preparations within 2 weeks prior to treatment.
• Active, known, or suspected autoimmune disease requiring systemic treatment.
• History of interstitial lung disease.
• Severe hypersensitivity to another monoclonal antibody.
• Has received prior radiotherapy within 2 weeks of start of study treatment.
• Has received a live vaccine within 28 days prior to the first dose of study treatment.
• History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
• History of myocarditis or congestive heart failure within 6 months of screening.
• Has a serious or uncontrolled medical disorder.
• Has a QT interval corrected for heart rate using Fridericia's formula (QTcF) > 480 msec, except for right bundle branch block.

Where it is running

• University of Iowa — Iowa City, Iowa, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Laboratoire de Recherche Translationnelle en Immunotherapie (LRTI), Gustave Roussy — Villejuif, France
• University of Athens — Athens, Greece
• University General Hospital Attikon — Athens, Greece
• Vall d'Hebron Hospital Hospital Universitario Vall d´Hebron (Vall d'Hebron University Hospital) — Barcelona, Spain
• Hospital Clinic Barcelona — Barcelona, Spain
• START Madrid CIO Clara Campal, Hospital Universitario HM Sanchinarro Unidad de Ensayos Fase I Panta 3 — Madrid, Spain
• Hospital Clinico Universitario de Valencia — Valencia, Spain
• The Clatterbridge Cancer Centre NHS Foundation Trust — Bebington, Merseyside, United Kingdom
• The Royal Marsden NHS Foundation Trust — London, United Kingdom
• Churchill Hospital — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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