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RP3

Phase 1

Advanced Solid Tumor | Monoclonal antibody | Oncology |Replimune Group, Inc.|Last Updated: Feb 27, 2026

Success Probability
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Market & Valuation
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment123
FDA Designations
No designations recorded
Clinical trial landscape

RP3 · 1 trial · 1 indication

Phase 1 1
NCT04735978Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid TumoursAdvanced Solid Tumor
ACTIVE NOT_RECRUITING123 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours
Advanced Solid Tumor
NCT04735978123
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Study Endpoints
Primary Endpoints
Incidence of dose limiting toxicities (DLTs) during the DLT period
From Day 1 up to 30 days after last dose

Percentage of participants with DLTs

Incidence and severity of treatment emergent adverse events (TEAEs)
From Day 1 up to 60 days after last dose

Percentage of participants with TEAEs

Incidence and severity of serious adverse events (SAEs)
From Day 1 up to 60 days after last dose

Percentage of participants with SAEs

Incidence of TEAEs ≥ Grade 3
From Day 1 up to 60 days after last dose

Percentage of participants with TEAEs ≥ Grade 3

Percentage of events requiring withdrawal
From Day 1 up to last dose (up to 8 weeks in escalation phase and up to 2 years in combination phase)

Percentage of participants experiencing events requiring withdrawal from treatment.

Recommended phase 2 dose (RP2D) of RP3
7 months

RP2D of RP3 based on the safety and response data collected during the dose escalation phase (Part 1)

Secondary Endpoints
Percentage of biologic activity
From Day 1 to 24 months following the last dose in dose escalation. From Day 1 to 100 days following the last dose in dose combination
Incidence of clearance of RP3 from blood and urine
From Day 1 to 60 days following the last dose in dose escalation. From Day 1 to 100 days following the last dose in dose combination
Percentage of participants with detectable RP3.
From Day 1 to 60 days following the last dose in dose escalation. From Day 1 to 100 days following the last dose in dose combination
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose escalation of RP3 - superficial and/or deep/visceral tumorsEXPERIMENTALDose escalation of RP3 alone in 2 cohorts with intratumoral (IT) injections including use of imaging guided injection for deep tumors.
Dose combination of RP3 and anti-PD1 therapy - superficial and/or deep/visceral tumorsEXPERIMENTALDose combination of RP3 and anti-PD1 therapy. IT injections of RP3 including use of imaging guided injection for deep tumors.
Seronegative cohortEXPERIMENTALDoses of RP3 (IT) in HSV seronegative participants.
Interventions
NameTypeDescription
RP3BIOLOGICALGenetically modified HSV-1
NivolumabBIOLOGICALanti-PD1 monoclonal antibody
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * 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...

Countries:United StatesFranceGreeceSpainUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumor")
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT04735978primaryCompletionDate: changed
LOWMay 24, 2026NCT04735978studyFirstPostDate: changed