Phase 1 Study of RP3 +/- PD1 Blockade in solid tumours
Research type
Research Study
Full title
An Open-Label, Multicenter, Phase 1 Study of RP3 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors
IRAS ID
285427
Contact name
Mark Middleton
Contact email
Sponsor organisation
Replimune Inc.
Eudract number
2020-002870-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 4 months, 0 days
Research summary
This is a Phase 1 Study of RP3 with and without other therapy in solid tumors. RP3 is a gene therapy product based on the herpes simplex virus that has been genetically changed to grow in and destroy cancer cells. RP3 is genetically changed to deliver a part of a protein from a gibbon ape leukaemia virus (GALV) that causes the tumor cells to combine and die. RP3 also delivers an antibody-like protein that targets an immune cell receptor called “CTLA-4”. This antibody-like protein will help the immune system further to fight the tumor. Finally, RP3 expresses a gene encoding for CD40 ligand and human 4-1BB ligand which helps in t cell activation, survival and increased anti-tumor activity. This anti-tumor response is expected to work alongside drugs known as immune checkpoint blockade agents including those targeting components of the programmed cell death pathway, PD-1/PD-L1.
This FIH study will include dose escalation and dose expansion parts.
The dose escalation portion (part 1) will include up to 18 solid tumor participants dosed with RP3 in three dose level cohorts by direct or ultrasound guided injection into superficial, subcutaneous or nodal tumors and by imaging guided injection into deeper lesions including visceral lesions. In the dose escalation portion, participants will receive up to 5 doses of RP3 given every two weeks. Participants with any injectable solid tumour where no other therapies are either available or likely to provide benefit will be enrolled in the study. Key objectives will include evaluation of safety, biological activity and determination of the highest tolerated dose.
There will also be a dose expansion portion (part 2) where up to 30 participants will receive a fixed dose of RP3 that is deemed to be safe in combination with Nivolumab (anti-PD-1 therapy).
Replimune Inc. is the sponsor. Study duration is 40 months.REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/LO/1080
Date of REC Opinion
1 Dec 2020
REC opinion
Further Information Favourable Opinion