Colorectal CancerPhase 2NCT04907539
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)
A Phase 2 study testing RXC004, Nivolumab and Denosumab in people with Colorectal Cancer, run by Redx Pharma Ltd at 22 sites in 4 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- RXC004, Nivolumab and Denosumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 8 Nov 2021to 2 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
United Kingdom7 sites
Queen Elizabeth Hospital - Clinical Reasearch
Birmingham, B152TH
Beatson West of Scotland Cancer Centre - Oncology
Glasgow, Scotland, G12 0YN
University College of London (UCL)
London, NW1 2PG
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
London, SW3 6JJ
Christie Hospital
Manchester, CB2 0QQ
Oxford Cancer Centre
Oxford, OX3 7LJ
The Royal Marsden Hospital (Surrey)
Surrey Quays, SM25PT
United States5 sites
UT MD Anderson Cancer Center
Houston, Texas, 77030-4000
Community Health Network Cancer Center North - Community Hospital Network
Indianapolis, Indiana, 46250
Lumi Research
Kingswood, Texas, 77339
OptumCare Cancer Care
Las Vegas, Nevada, 89102
Providence Medical Foundation
Santa Rosa, California, 95403
South Korea5 sites
National Cancer Center
Goyang-si, Gyeonggido [Kyonggi-do], 10408
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System - Medical Oncology
Seoul, 3722
Asan Medical Center - Oncology
Seoul, 5505
Samsung Medical Center - Hematology-Oncology
Seoul, 6351
Spain5 sites
Hospital del Mar
Barcelona, 08003
Hospital Universitario Vall d'Hebrón
Barcelona, 08035
Hospital Clìnic de Barcelona
Barcelona, 08036
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Virgen del Rocio
Seville, 41013
About this study
Official 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 (PORCUPINE)
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.
Read the detailed description
The study is composed of two arms, RXC004 monotherapy (Arm A) and RXC004 in combination with nivolumab (Arm B). 20 evaluable patients will be enrolled in Arm A and 20 eligible patients in Arm B.
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
- Colorectal Cancer
- Being tested
- RXC004, Nivolumab, Denosumab
- Keywords
- Open label, RXC004, Nivolumab, Ring finger protein 43, R-spondin, Efficacy, Safety, Pharmacokinetics
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RXC004Drug
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.
NivolumabBiological
Nivolumab will be administered via IV infusion, 480 mg q4w.
DenosumabBiological
Denosumab will be administered via subcutaneous (SC) injection, 120 mg once every month.
Use: Prophylactic
| Study group | Role | What they receive |
|---|---|---|
| Arm A: RXC004 monotherapy | Experimental | 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). Receives: Drug: RXC004; Biological: Denosumab |
| Arm B: RXC004 + nivolumab | Experimental | 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). Receives: Drug: RXC004; Biological: Nivolumab; Biological: Denosumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
RXC004 Monotherapy (Arm A): Disease Control Rate (DCR) Using Each Patient's Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1)
The anti-tumour activity of RXC004 monotherapy was evaluated. DCR is defined as the percentage of patients with a BOR of either complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks post baseline.
Measured: Up to 28 months
RXC004+Nivolumab Combination Therapy (Arm B): Objective Response Rate (ORR) Using Each Patient's BOR According to RECIST 1.1
The anti-tumour activity as a combination therapy of RXC004 +nivolumab was evaluated. ORR is defined as the percentage of patients with a BOR of CR or PR based on local investigator assessment, as defined in RECIST 1.1.
Measured: Up to 28 months
Secondary outcomes (15)
Best Percentage Change in Tumor Size
The preliminary efficacy of RXC004 monotherapy and combination therapy of RXC004 + nivolumab was evaluated. The best percentage change in tumour size was determined at a patient level. Percentage change in tumour size was derived at each visit by the percentage change from baseline in the sum of diameters of target lesions. The best percentage change in tumour size was the patients value representing the largest decrease (or smallest increase) from baseline in tumour size.
Measured: Up to 28 months
Progression Free Survival (PFS)
The preliminary efficacy of RXC004 monotherapy and combination therapy of RXC004 + nivolumab was evaluated. PFS is defined as the time from first dose of study treatment until the date of disease progression or death (by any cause in the absence of progression).
Measured: Up to 28 months
Duration of Response (DOR)
The preliminary efficacy of RXC004 monotherapy and combination therapy of RXC004 + nivolumab was evaluated. The DOR is as the time from the date of first documented response until date of documented progression or death in the absence of disease progression. DOR was not calculated as 1 patient had PR, and 0 patient had CR. As pre-specified in the SAP that after the review of the available data, DOR would not be summarized and listed.
Measured: Up to 28 months
RXC004 Monotherapy (Arm A): Objective Response Rate (ORR) Using Investigator Assessments According to RECIST 1.1
The preliminary efficacy of RXC004 monotherapy was evaluated. ORR is defined as the percentage of patients with a BOR of CR or PR based on local investigator assessment as defined in RECIST 1.1.
Measured: Up to 28 months
RXC004 + Nivolumab Combination Therapy (Arm B): Disease Control Rate Using Investigator Assessments According to RECIST 1.1
The preliminary efficacy of combination therapy of RXC004 + nivolumab was evaluated. DCR is defined as the percentage of patients with a BOR of either CR, PR or SD for at least 16 weeks post baseline.
Measured: Up to 28 months
Overall Survival (OS)
The preliminary efficacy of RXC004 monotherapy and combination therapy of RXC004 + nivolumab was evaluated. OS is defined as the time from first day of study treatment until death due to any cause.
Measured: Up to 28 months
Maximum Observed Plasma Concentration (Cmax)
The pharmacokinetic (PK) (Cmax) of RXC004 in monotherapy and in combination therapy with nivolumab was evaluated.
Measured: On Cycle 0 Day 1 (3-7 days cycle in length) and Cycle 1 Day 15 (28 days cycle in length)
Time to Maximum Plasma Concentration (Tmax)
The PK (Tmax) of RXC004 in monotherapy and in combination therapy with nivolumab was evaluated.
Measured: On Cycle 0 Day 1 (3-7 days cycle in length) and Cycle 1 Day 15 (28 days cycle in length)
Minimum Observed Concentration Across the Dosing Interval (Cmin)
The PK (Cmin) of RXC004 in monotherapy and in combination therapy with nivolumab was evaluated.
Measured: On Cycle 1 Day 15 (28 days cycle in length)
Terminal Rate Constant (λz)
The PK (λz) of RXC004 in monotherapy and in combination therapy with nivolumab was evaluated.
Measured: On Cycle 0 Day 1 (3-7 days cycle in length)
Terminal Half-life (t½)
The PK (t½) of RXC004 in monotherapy and in combination therapy with nivolumab was evaluated.
Measured: On Cycle 0 Day 1 (3-7 days cycle in length)
Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC0-∞)
The PK (AUC0-∞) of RXC004 in monotherapy and in combination therapy with nivolumab was evaluated.
Measured: On Cycle 0 Day 1 (3-7 days cycle in length)
Total Plasma Clearance After Oral Administration (CL/F)
The PK (CL/F) of RXC004 in monotherapy and in combination therapy with nivolumab was evaluated.
Measured: On Cycle 0 Day 1 (3-7 days cycle in length)
Apparent Volume of Distribution After Oral Administration (Vz/F)
The PK (Vz/F) of RXC004 in monotherapy and in combination therapy with nivolumab was evaluated.
Measured: On Cycle 0 Day 1 (3-7 days cycle in length)
Number of Patients With Adverse Events (AEs)
The safety and tolerability profile of RXC004 monotherapy and RXC004 + nivolumab combination was evaluated. The grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse events (CTCAE) latest version was utilized for all events with an assigned CTCAE grading. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Life-threatening, urgent intervention required; Grade 5: Death related to AE.
Measured: From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start8 Nov 2021
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Redx Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907539
- Sponsor's protocol ID
- RXC004/0002
- Status last verified
- Mar 2025
- First submitted
- 25 May 2021
- Last updated
- 16 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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 (PORCUPINE)
- ClinicalTrials.gov ID
- NCT04907539
- Acronym / sponsor ID
- RXC004/0002
- Conditions
- Colorectal Cancer
- Keywords
- Open label, RXC004, Nivolumab, Ring finger protein 43, R-spondin, Efficacy, Safety, Pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Redx Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Posted 16 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is composed of two arms, RXC004 monotherapy (Arm A) and RXC004 in combination with nivolumab (Arm B). 20 evaluable patients will be enrolled in Arm A and 20 eligible patients in Arm B.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: RXC004 monotherapy | Experimental | Drug: RXC004, Biological: DenosumabPatients 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). |
| Arm B: RXC004 + nivolumab | Experimental | Drug: RXC004, Biological: Nivolumab, Biological: DenosumabPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histological documentation of metastatic (Stage IV) Colorectal cancer (CRC) and
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RXC004RXC004 will be administered orally, 2 mg QD (Monotherapy); and 1.5 mg QD (Combination therapy) Dose Formulation: 0.5 mg or 1 mg capsules. | Drug | Arm A: RXC004 monotherapy, Arm B: RXC004 + nivolumab |
| NivolumabNivolumab will be administered via IV infusion, 480 mg q4w. | Biological | Arm B: RXC004 + nivolumab |
| DenosumabDenosumab will be administered via subcutaneous (SC) injection, 120 mg once every month. Use: Prophylactic | Biological | Arm A: RXC004 monotherapy, Arm B: RXC004 + nivolumab |
Primary outcome
RXC004 Monotherapy (Arm A): Disease Control Rate (DCR) Using Each Patient's Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1)
Time frame: Up to 28 months
The anti-tumour activity of RXC004 monotherapy was evaluated. DCR is defined as the percentage of patients with a BOR of either complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks post baseline.
RXC004+Nivolumab Combination Therapy (Arm B): Objective Response Rate (ORR) Using Each Patient's BOR According to RECIST 1.1
Time frame: Up to 28 months
The anti-tumour activity as a combination therapy of RXC004 +nivolumab was evaluated. ORR is defined as the percentage of patients with a BOR of CR or PR based on local investigator assessment, as defined in RECIST 1.1.
15 secondary outcomes
Best Percentage Change in Tumor Size
Time frame: Up to 28 months
Progression Free Survival (PFS)
Time frame: Up to 28 months
Duration of Response (DOR)
Time frame: Up to 28 months
RXC004 Monotherapy (Arm A): Objective Response Rate (ORR) Using Investigator Assessments According to RECIST 1.1
Time frame: Up to 28 months
RXC004 + Nivolumab Combination Therapy (Arm B): Disease Control Rate Using Investigator Assessments According to RECIST 1.1
Time frame: Up to 28 months
Overall Survival (OS)
Time frame: Up to 28 months
Maximum Observed Plasma Concentration (Cmax)
Time frame: On Cycle 0 Day 1 (3-7 days cycle in length) and Cycle 1 Day 15 (28 days cycle in length)
Time to Maximum Plasma Concentration (Tmax)
Time frame: On Cycle 0 Day 1 (3-7 days cycle in length) and Cycle 1 Day 15 (28 days cycle in length)
Minimum Observed Concentration Across the Dosing Interval (Cmin)
Time frame: On Cycle 1 Day 15 (28 days cycle in length)
Terminal Rate Constant (λz)
Time frame: On Cycle 0 Day 1 (3-7 days cycle in length)
Terminal Half-life (t½)
Time frame: On Cycle 0 Day 1 (3-7 days cycle in length)
Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC0-∞)
Time frame: On Cycle 0 Day 1 (3-7 days cycle in length)
Total Plasma Clearance After Oral Administration (CL/F)
Time frame: On Cycle 0 Day 1 (3-7 days cycle in length)
Apparent Volume of Distribution After Oral Administration (Vz/F)
Time frame: On Cycle 0 Day 1 (3-7 days cycle in length)
Number of Patients With Adverse Events (AEs)
Time frame: From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RXC004, Nivolumab and Denosumab in people with Colorectal Cancer, run by Redx Pharma Ltd at 22 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom, United States, South Korea, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RXC004 Monotherapy (Arm A): Disease Control Rate (DCR) Using Each Patient's Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1) (time frame: Up to 28 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.