Phase II Study to Assess Efficacy of RXC004 +/- Nivolumab in RNF43/RSP
Research type
Research Study
Full title
A Multi-arm, Phase II, Open-Label, Multicentre Study to Assess the Preliminary Efficacy of RXC004 in Monotherapy and in Combination with Nivolumab, in Patients with Ring Finger Protein 43 (RNF43) or R-spondin (RSPO) Aberrated, Metastatic, Microsatellite Stable, Colorectal Cancer who have Progressed following Therapy with Current Standard of Care
IRAS ID
292503
Contact name
Charlotte Pai
Contact email
Sponsor organisation
Redx Pharma Plc
Eudract number
2020-003132-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 0 days
Research summary
Colorectal cancer (CRC) accounts for 10% of all cancer related deaths worldwide. Approximately 20% to 25% of newly diagnosed CRC is metastatic at presentation and approximately 70% will become metastatic. Typically treatment includes chemotherapy, targeted monotherapy or immunotherapy treatment. The median survival of patients with metastatic CRC is 30 months (Van Cutsem et al). There is therefore still a significant unmet medical need for additional treatment for metastatic CRC.
Microsatellite stable (MSS) colorectal cancer, which represents approximately 85% of colorectal cancer needs more treatment options on the market taking into account the median survival of patients affected by this disease.
This study is being done on patients that have a specific gene mutation in their colorectal cancer and they progressed after their first line of standard of care. The objective is to find out if a new investigational drug RXC004 and RXC004 in combination with Nivolumab is effective and could help to improve quality of life and overall survival of patients with metastatic microsatellite stable CRC.
RXC004 will be given orally as capsules and some study participants will also receive Nivolumab intravenously. For the patients that will receive Nivolumab rescue medication for potential immune reactions will be available on each investigator site. Also Denosumab will be provided by the sponsor and administered as a subcutaneous prophylactic once every month during trial period to maximise bone safety to each enrolled patient.
There will be approximately 50 patients’ participants in this study at about 25 study sites in about 4 countries.
The study is being sponsored by Redx Pharma Plc.REC name
Wales REC 1
REC reference
21/WA/0033
Date of REC Opinion
11 Mar 2021
REC opinion
Further Information Favourable Opinion