Study of RP2 Monotherapy and RP2 in Combination With Nivolumab in Patients With Solid Tumors

Sponsor
Replimune, Inc.
Study ID
NCT04336241
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Cancer

Eligibility Criteria

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

Interventions

  • RP2 — BIOLOGICAL
    Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation
  • nivolumab — BIOLOGICAL
    Programmed death receptor (PD-1) blocking antibody

Study Details

RP2-001-18 is a Phase 1, multicenter, open label, single agent dose escalation and combination treatment study of RP2 in adult subjects with advanced solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

Key Dates

Start date
Oct 17, 2019
Status verified
Feb 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

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

Arms

  • Experimental: Dose escalation of RP2 - superficial tumors
    Dose escalation of RP2 alone in 3 cohorts with IT injections in superficial tumors.
  • Experimental: Dose escalation of RP2 - deep/visceral tumors
    Dose escalation of RP2 alone in 3 cohorts with imaging guided IT injections in deep/visceral tumors.
  • Experimental: Dose expansion of RP2 and nivolumab - superficial tumors
    Doses of RP2 (IT) in superficial tumors with nivolumab (IV).
  • Experimental: Dose expansion of RP2 and nivolumab - deep/visceral tumors
    Imaging guided doses of RP2 (IT) in deep/visceral tumors.
  • Experimental: Seronegative cohort
    Doses of RP2 (IT) in HSV seronegative participants.

Primary Outcome Measure

Percentage of adverse events (AEs) [ Time Frame: From Day 1 up to 60 days after last dose ]

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