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)

Part of paid clinical trials in Santa Rosa, California.

Sponsor
Redx Pharma Ltd
Study ID
NCT04907539
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RXC004 — DRUG
    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 — BIOLOGICAL
    Nivolumab will be administered via IV infusion, 480 mg q4w.
  • Denosumab — BIOLOGICAL
    Denosumab will be administered via subcutaneous (SC) injection, 120 mg once every month. Use: Prophylactic

Study Details

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 Dates

Start date
Nov 8, 2021
Status verified
Mar 2025
Primary completion
Apr 2, 2024
Completion
Apr 2, 2024

Study Design

Enrollment
25 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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).
  • Experimental: 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).

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 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Providence Medical FoundationSanta RosaCalifornia95403-
Community Health Network Cancer Center North - Community Hospital NetworkIndianapolisIndiana46250-
OptumCare Cancer CareLas VegasNevada89102-
UT MD Anderson Cancer CenterHoustonTexas77030-4000-
Lumi ResearchKingswoodTexas77339-

Related coverage on Hipa.ai

Find similar trials in Santa Rosa, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Providence Medical Foundation· Santa Rosa, CACommunity Health Network Cancer Center North - Community Hospital Network· Indianapolis, INOptumCare Cancer Care· Las Vegas, NVUT MD Anderson Cancer Center· Houston, TXLumi Research· Kingswood, TX

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