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)
NCT ID: NCT04907539
Last Updated: 2025-04-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2021-11-08
2024-04-02
Brief Summary
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Detailed Description
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The study initially opened with Arm A; Arm B will be opened once a recommended Phase II dose (RP2D) for RXC004 in combination with nivolumab is established in the phase I dose escalation study (NCT03447470).
Once Arm B is opened, patients who are eligible for both Arm A and Arm B will be randomised 2:1 to Arm B: Arm A in an open-label manner.
Patients in Arm A may be treated with RXC004 + nivolumab if they have progressive disease on the 8 week scan, as long as they are eligible for Arm B and have Sponsor approval.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Arm A: RXC004 monotherapy
Patients will receive RXC004 (2 mg once daily \[QD\], orally).
Patients in Arm A may crossover to Arm B treatment if they have progressive disease on the first Response Evaluation Criteria in Solid Tumours, (RECIST) scan (if Arm B is open at the time of progression).
RXC004
RXC004 will be administered orally, 2 mg QD (Monotherapy); and 1.5 mg QD (Combination therapy)
Dose Formulation: 0.5 mg or 1 mg capsules.
Denosumab
Denosumab will be administered via subcutaneous (SC) injection, 120 mg once every month.
Use: Prophylactic
Arm B: RXC004 + nivolumab
Patients will receive RXC004 (1.5 mg QD, orally) in combination with nivolumab (480 mg every 4 weeks \[q4w\], intravenous \[IV\] infusion).
Arm B will be opened once a RP2D for RXC004 in combination with nivolumab is established in the phase I dose escalation study (NCT03447470). RXC004 dose to be used in combination with nivolumab will be based on data from the phase 1 study (NCT03447470).
RXC004
RXC004 will be administered orally, 2 mg QD (Monotherapy); and 1.5 mg QD (Combination therapy)
Dose Formulation: 0.5 mg or 1 mg capsules.
Nivolumab
Nivolumab will be administered via IV infusion, 480 mg q4w.
Denosumab
Denosumab will be administered via subcutaneous (SC) injection, 120 mg once every month.
Use: Prophylactic
Interventions
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RXC004
RXC004 will be administered orally, 2 mg QD (Monotherapy); and 1.5 mg QD (Combination therapy)
Dose Formulation: 0.5 mg or 1 mg capsules.
Nivolumab
Nivolumab will be administered via IV infusion, 480 mg q4w.
Denosumab
Denosumab will be administered via subcutaneous (SC) injection, 120 mg once every month.
Use: Prophylactic
Eligibility Criteria
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Inclusion Criteria
1. Documented tumour tissue aberration in RNF43 and/or RSPO
2. 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.
* 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).
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Redx Pharma Ltd
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RXC004/0002
Identifier Type: -
Identifier Source: org_study_id
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