Clinical trial · Interventional
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 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)
NCT04907539CI-TRIAL-00088618completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: RXC004 monotherapy
- description
- 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).
- interventionNames
- Drug: RXC004
- Biological: Denosumab
- type
- EXPERIMENTAL
- label
- Arm B: RXC004 + nivolumab
- description
- 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).
- interventionNames
- Drug: RXC004
- Biological: Nivolumab
- Biological: Denosumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological documentation of metastatic (Stage IV) Colorectal cancer (CRC) and 1. Documented tumour tissue aberration in RNF43 and/or RSPO 2. 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 * 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). Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.