A Study to Assess Efficacy of RXC004 +/- Nivolumab in Ring Finger Protein 43 (RNF43) or R-spondin (RSPO) Aberrated, Metastatic, Microsatellite Stable, Colorectal Cancer After Progression on Standard of Care (SOC)

Completed · Phase 2

Conditions studied: Colorectal Cancer

In brief

This is a Phase II, open label, multicentre, multi-arm, study to evaluate the preliminary efficacy and safety of RXC004 as monotherapy and in combination with nivolumab in patients with Ring finger protein 43 (RNF43) or R-spondin (RSPO) aberrated, microsatellite stable (MSS), colorectal cancer (CRC), that have progressed following current standard of care treatment.

Key facts

Study ID

NCT04907539

Run by

Redx Pharma Ltd

People needed

25

Starts

2021-11-08

Expected to finish

2024-04-02

Last updated by the study team

2025-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological documentation of metastatic (Stage IV) Colorectal cancer (CRC) and
• Documented tumour tissue aberration in RNF43 and/or RSPO
• Documented confirmation of microsatellite stable (MSS) status
• Patients must have had documented radiological progression following a minimum of 1 prior SOC treatment regimen for metastatic disease
• Eastern Cooperative Oncology Group performance status 0 or 1
• At least one lesion that is measurable by RECIST 1.1 at baseline
• Patients must have at least one lesion suitable for biopsy at screening and be willing to provide mandatory tumour biopsy samples
• Patients with adequate organ functions
• Female patients of childbearing potential must have a negative pregnancy test prior to start of dosing
• Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 5 months after the last dose of study drug.
• For patients on RXC004 monotherapy treatment (Arm A) the following inclusion criteria will also apply to enter the RXC004 + nivolumab treatment phase:
• Patients must have had documented RECIST1.1 defined radiological progression on RXC004 monotherapy treatment on the first scheduled scan (week 8 +/- 1 week)
• Patients must receive Cycle 1 Day 1 of combination study treatment within 28 days of the first scheduled scan (week 8 +/- 1 week).

You may not qualify if…

• Prior therapy with a compound of the same mechanism of action as RXC004
• Patients at higher risk of bone fractures
• Any known uncontrolled inter-current illness or persistent clinically significant toxicity related to prior anti-cancer treatment
• Patients who have any history of an active (requiring treatment) other malignancy within 2 years of study entry
• Patients with known or suspected brain metastases
• Use of anti-neoplastic agents, immunosuppressants and other investigational drugs
• Patients with a known hypersensitivity to any RXC004 excipients
• Patients with a contra-indication for denosumab treatment
• Patients who are pregnant or breast-feeding
• Use of any live or live-attenuated vaccines against infectious diseases (e.g., influenza nasal spray, varicella) within 4 weeks (28 days) of initiation of study treatment
• Patients with a mean resting corrected QTcF >470 ms, obtained from triplicate electrocardiograms performed at screening
• For patients on RXC004 + nivolumab combination treatment (Arm B or Arm A RXC004 + nivolumab treatment phase):
• Patients with any contraindication to the use of nivolumab
• Patients with active or prior documented autoimmune or inflammatory disorders within the past 5 years
• Patients with active infections, including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus
• Patients with a history of allogeneic organ transplant or active primary immunodeficiency
• Patients with a known hypersensitivity to nivolumab or any of the excipients of the product

Where it is running

• Providence Medical Foundation — Santa Rosa, California, United States
• Community Health Network Cancer Center North - Community Hospital Network — Indianapolis, Indiana, United States
• OptumCare Cancer Care — Las Vegas, Nevada, United States
• UT MD Anderson Cancer Center — Houston, Texas, United States
• Lumi Research — Kingswood, Texas, United States
• National Cancer Center — Goyang-si, Gyeonggido [Kyonggi-do], South Korea
• Seoul National University Hospital — Seoul, South Korea
• Severance Hospital, Yonsei University Health System - Medical Oncology — Seoul, South Korea
• Asan Medical Center - Oncology — Seoul, South Korea
• Samsung Medical Center - Hematology-Oncology — Seoul, South Korea
• Hospital del Mar — Barcelona, Spain
• Hospital Universitario Vall d'Hebrón — Barcelona, Spain
• Hospital Clìnic de Barcelona — Barcelona, Spain
• Hospital Universitario 12 de Octubre — Madrid, Spain
• Hospital Universitario Virgen del Rocio — Seville, Spain
• Beatson West of Scotland Cancer Centre - Oncology — Glasgow, Scotland, United Kingdom
• Queen Elizabeth Hospital - Clinical Reasearch — Birmingham, United Kingdom
• University College of London (UCL) — London, United Kingdom
• The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital — London, United Kingdom
• Christie Hospital — Manchester, United Kingdom
• Oxford Cancer Centre — Oxford, United Kingdom
• The Royal Marsden Hospital (Surrey) — Surrey Quays, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.