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Monoclonal Antibodies

RXC004 + Nivolumab for Colorectal Cancer

Phase 2
Recruiting
Research Sponsored by Redx Pharma Plc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a new drug, RXC004, to treat colorectal cancer that has progressed after standard care treatment. The trial will evaluate the safety and efficacy of RXC004 as monotherapy and in combination with nivolumab.

Eligible Conditions
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
RXC004 + nivolumab Combination: Objective response rate (ORR) using each patients BOR according to RECIST 1.1
RXC004 Monotherapy: Disease control rate (DCR) using each patients Best Overall Response (BOR) according to Response Evaluation Criteria in Solid Tumours, version 1.1 (RECIST 1.1)
Secondary outcome measures
Apparent volume of distribution after oral administration (Vz/F)
Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)
Duration of response (DoR)
+12 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: RXC004 + nivolumabExperimental Treatment3 Interventions
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).
Group II: Arm A: RXC004 monotherapyExperimental Treatment2 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RXC004
2021
Completed Phase 2
~50
Nivolumab
2014
Completed Phase 3
~4750
Denosumab
2017
Completed Phase 4
~12500

Find a Location

Who is running the clinical trial?

Redx Pharma PlcLead Sponsor
4 Previous Clinical Trials
245 Total Patients Enrolled

Media Library

Nivolumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04907539 — Phase 2
Colorectal Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04907539 — Phase 2
Nivolumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04907539 — Phase 2
Colorectal Cancer Research Study Groups: Arm A: RXC004 monotherapy, Arm B: RXC004 + nivolumab

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What hazards could people encounter when taking RXC004?

"RXC004 is in its second phase of clinical trials, with existing data confirming safety but not efficacy. As such, our team at Power estimated the drug's safety to be a 2 on their scale from 1-3."

Answered by AI

What are the desired outcomes from this experiment?

"The 20-month clinical trial seeks to evaluate the efficacy of RXC004 Monotherapy using patients' Best Overall Response (BOR) through Response Evaluation Criteria in Solid Tumours, version 1.1 (RECIST 1.1). Secondary objectives include assessing the preliminary efficacy of RXC004 + Nivolumab Combination by determining Disease Control Rate (DCR), measuring Percentage Change in sum of target lesions and Area under plasma concentration-time curve from zero to infinity (AUC0∞)."

Answered by AI

In what medical scenarios is RXC004 usually proscribed?

"RXC004 is indicated for the treatment of malignant neoplasms, as well as unresectable melanoma and squamous cell carcinomas with a high risk of reoccurrence."

Answered by AI

Has RXC004 been the subject of any prior trials?

"RXC004 was first trialed in 2012 by Local Institution. Since then, 364 experiments have already been finished and 762 are currently being conducted at Indianapolis, Indiana."

Answered by AI

Is this the inaugural research project in its field?

"Presently, 762 live trials for RXC004 are taking place across 2410 cities and 53 nations. The initial testing of this drug was sponsored by Ono Pharmaceutical Co. Ltd in 2012 and involved 659 individuals during their Phase 1 & 2 clinical trial stages. Since then, 364 studies have been concluded successfully."

Answered by AI

How many participants have signed up for the experiment so far?

"Affirmative. Clinicaltrials.gov provides evidence that this medical experiment, which was first made available on November 8th 2021, is currently recruiting patients. About 50 trial participants need to be sourced from 4 separate locations."

Answered by AI

Is there an ongoing recruitment phase for this research endeavor?

"Indeed, the information on clinical trials.gov shows that this examination is actively accepting applications for participation. The initial posting of the trial was November 8th 2021 and it was most recently revised on October 26th 2022. 50 participants are needed across 4 distinct locations."

Answered by AI

How wide-reaching is the scope of this experiment?

"This trial is being conducted at four different locations, such as the Community Health Network Cancer Center North - Community Hospital Network in Indianapolis and Lumi Research in Kingswood. Additionally, the UT MD Anderson Cancer Centre located in Houston is also hosting this experiment, along with one other establishment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
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)
2021. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04907539.
~15 spots leftby Apr 2025
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