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Monoclonal Antibodies
RXC004 + Nivolumab for Colorectal Cancer
Phase 2
Waitlist Available
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 29 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 29 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 29 months
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 moreTrial 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
~70
Nivolumab
2014
Completed Phase 3
~4750
Denosumab
2013
Completed Phase 4
~12010
Find a Location
Who is running the clinical trial?
Redx Pharma PlcLead Sponsor
4 Previous Clinical Trials
245 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious illness or ongoing side effects from previous cancer treatment that are not under control.You have had another type of cancer that required treatment within the past 2 years.You are allergic to any of the ingredients in the RXC004 medication.You have already been treated with a similar medication to RXC004.You have a higher chance of breaking your bones.You are currently taking any medications for cancer treatment, immune system suppression, or experimental drugs.This criterion is specific to patients who are receiving the combination treatment of RXC004 and nivolumab (either in Arm B or Arm A of the study).You have had an autoimmune or inflammatory disorder in the past 5 years.You have tumors that have spread to your brain or there is a suspicion that they have.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: RXC004 monotherapy
- Group 2: Arm B: RXC004 + nivolumab
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