Phase 1 Study of RP2 +/- PD1 Blockade in solid tumours
Research type
Research Study
Full title
An Open-Label, Multicenter, Phase 1 Study of RP2 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors
IRAS ID
262031
Contact name
Susan Doleman
Contact email
Sponsor organisation
Replimune, Inc.
Eudract number
2018-003765-33
Duration of Study in the UK
3 years, 7 months, days
Research summary
This is a Phase I Study of RP2 with and without other therapy in solid tumours. RP2 is a gene therapy product based on herpes simplex virus 1, able to replicate in tumour cells, resulting in tumour cell death. RP2 delivers the protein for human GM-CSF to the tumour cells, increasing the effect of the immune response against the tumour. RP2 also delivers a part of a protein from a gibbon ape leukeamia virus (GALV) that causes the tumour cells to fuse and cause tumour cell death. Finally RP2 delivers an antibody-like protein that targets an immune cell receptor called “CTLA-4”. This antibody-like protein will act to help further increase the immune response to the tumour.This anti-tumour 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 first in human study will include dose escalation and dose expansion parts.
The dose escalation portion (part 1) will include up to 24 solid tumour participants dosed with RP2 in three dose level cohorts by direct or ultrasound guided injection into superficial, subcutaneous or nodal tumours and by imaging guided injection into deeper lesions including visceral lesions. In the dose escalation portion, participants will receive up to 5 doses of RP2 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 12 participants will receive a fixed dose of RP2, that is deemed to be safe in combination with Nivolumab (anti-PD-1 therapy).
Replimune Inc. is the sponsor and study duration is 44 months.REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0147
Date of REC Opinion
22 May 2019
REC opinion
Further Information Favourable Opinion