A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2)

• Status: Not yet recruiting
• Trial end date: 2023-06-10
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the preliminary efficacy and safety of RXC004 monotherapy in advanced solid tumours that have progressed following SoC treatment.

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

Details

• Lead Sponsor: Redx Pharma Plc
• Treatments: Denosumab

Criteria

Core Inclusion Criteria:

• At least one lesion that is measurable by RECIST 1.1 at baseline (within 28 days prior to start of study treatment).

• Mandatory paired biopsies; Patients must have at least one lesion suitable for biopsy at screening

• Adequate organ and marrow function

• 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.

Module 1 (PDAC) Specific Inclusion Criteria

• Histological documentation of advanced (unresectable)/metastatic (Stage III/IV) PDAC, with documented loss of function tumour mutation in RNF43

• Patients must have received one prior systemic treatment for advanced (unresectable)/metastatic PDAC (Stage III/IV), with clear evidence of radiological disease progression

• Patients must be enrolled and receive first dose of study treatment within 6 weeks of radiologically confirmed RECIST1.1 progression

• Karnofsky performance status ≥70.

Module 2 (BTC) Specific Inclusion Criteria

• Histological documentation of advanced (unresectable)/metastatic (Stage III/IV) BTC (intrahepatic or extrahepatic cholangiocarcinoma, ampulla of Vater, or gallbladder cancer)

• Patients must have received one prior systemic treatment for advanced (unresectable)/metastatic BTC, with clear evidence of radiological disease progression

• Patients must be enrolled and receive first dose of study treatment within 6 weeks of radiologically confirmed RECIST1.1 progression

• ECOG status 0 or 1.

Core 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 and other investigational drugs within 4 weeks prior to the first dose of study treatment

• Patients with a known hypersensitivity to any RXC004 excipients

• Patients with a contra-indication for denosumab treatment

• Patients who are pregnant or breast-feeding

• Known active human immunodeficiency viruses (HIV), hepatitis B (HBV), or hepatitis C (HCV) infections

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