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)

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Redx Pharma Plc
• Treatments: Denosumab; Nivolumab

Criteria

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 RECIST1.1 defined 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.

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

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

• Use of any live vaccines against infectious diseases (e.g., influenza, varicella) within 4 weeks (28 days) of initiation of study treatment

• 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