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RP3

Phase 1

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

Target and mechanism

Molecular targetCD40L/4-1BBL/CTLA-4
ModalityMonoclonal antibody

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 TumorUnlock trial analytics

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")

Frequently asked questions about RP3

What is RP3 used for in advanced solid tumors?

RP3 is an investigational monoclonal antibody being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is being evaluated as a potential therapy for patients with advanced solid tumors.

What does RP3 target?

RP3 targets CD40L, 4-1BBL, and CTLA-4. These are molecular targets involved in immune system regulation. By targeting these molecules, RP3 is designed to modulate immune responses in the context of cancer treatment for advanced solid tumors.

Who makes RP3?

RP3 is being developed by Replimune Group, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol REPL. Replimune is conducting clinical trials to evaluate RP3 as a potential treatment for advanced solid tumors.

What phase is RP3 in?

RP3 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied in an active clinical trial for the treatment of advanced solid tumors.

What clinical trials is RP3 in?

RP3 is being studied in a Phase 1 clinical trial with the identifier NCT04735978. This trial is titled "Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours." The trial is active but not recruiting, with an enrollment of 123 participants.

Is RP3 the same as any other drug?

RP3 is a distinct investigational drug being developed by Replimune Group, Inc. It is not known to be the same as any other approved or investigational drug. RP3 is being studied as a monotherapy and in combination with nivolumab for advanced solid tumors.