At a glance
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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)
In Brief
A Phase 2 clinical trial evaluating RXC004, Nivolumab, and 1 other intervention for Colorectal Cancer. Completed, enrolled 25 participants across 22 sites in 4 countries.
Detailed 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 progressed following current standard of care treatment.
Study Details
Timeline
Interventions
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 will be administered via IV infusion, 480 mg q4w.
Denosumab will be administered via subcutaneous (SC) injection, 120 mg once every month. Use: Prophylactic