Phase 1/2 Study of RP1 +/- other therapies in solid tumours
Research type
Research Study
Full title
An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors
IRAS ID
225425
Contact name
Kevin Harrington
Contact email
Sponsor organisation
Replimune Limited
Eudract number
2016-004548-12
Duration of Study in the UK
4 years, 5 months, 0 days
Research summary
This is a Phase I/II Study of RP1 with and without other therapies in solid tumours. RP1 is a gene therapy product based on herpes simplex virus 1, able to replicate in tumour cells, resulting in tumour cell death. RP1 delivers the gene for human GM-CSF to the tumour cells, increasing the effect of the immune response against the tumour. This anti-tumour response is expected to work alongside drugs known as immune checkpoint blockade agents such as those targeting components of the programmed cell death pathway, PD-1/PD-L1.
This first in human study will include Phase I (Part 1) and Phase II (Part 2) portions.
The Part 1 dose escalation portion will include up to 36 solid tumour patients, enrolled in two parallel series, one for direct injection into superficial and nodal lesions and the other for imaging guided injection into deeper seated tumours. Each dose rising series will include up to three dose level groups. Participants with any injectable solid tumour where no other therapies are either available or likely to provide benefit will be enrolled in Part 1 of 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 where participants will receive a fixed dose of RP1, that is deemed to be safe in combination with Nivolumab.
In Part 2, RP1 will be given with anti-PD-1 therapy in cohorts of specific tumour types. The tumour types selected will include tumours where there is rationale for combined treatment of RP1 and anti-PD-1 therapy. Approximately 120 participants will be enrolled in Part 2 of the study.
The study is being sponsored by Replimune and is expected to last for approximately 32 months.REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0314
Date of REC Opinion
30 Aug 2017
REC opinion
Further Information Favourable Opinion