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

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Replimune, Inc.
Study ID
NCT04735978
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RP3 — BIOLOGICAL
    Genetically modified HSV-1
  • Nivolumab — BIOLOGICAL
    anti-PD1 monoclonal antibody

Study Details

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 Dates

Start date
Dec 29, 2020
Status verified
Feb 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
123 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation of RP3 - superficial and/or deep/visceral tumors
    Dose escalation of RP3 alone in 2 cohorts with intratumoral (IT) injections including use of imaging guided injection for deep tumors.
  • Experimental: Dose combination of RP3 and anti-PD1 therapy - superficial and/or deep/visceral tumors
    Dose combination of RP3 and anti-PD1 therapy. IT injections of RP3 including use of imaging guided injection for deep tumors.
  • Experimental: Seronegative cohort
    Doses of RP3 (IT) in HSV seronegative participants.

Primary Outcome Measure

Incidence of dose limiting toxicities (DLTs) during the DLT period [ Time Frame: From Day 1 up to 30 days after last dose ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Iowa City, IA

By research site
University of Iowa· Iowa City, IAUPMC Hillman Cancer Center· Pittsburgh, PAMD Anderson Cancer Center· Houston, TX

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