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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.
Full 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
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Inclusion criteria
Note: Predefined inclusion criteria may apply for each additional expansion cohort.
Exclusion criteria
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):
Primary purpose
Allocation
Interventional model
Masking
123 participants in 3 patient groups
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Central trial contact
Clinical Trials at Replimune
Data sourced from clinicaltrials.gov
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