Status:
COMPLETED
A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2)
Lead Sponsor:
Redx Pharma Ltd
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Advanced Solid Tumours
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is to evaluate the preliminary efficacy and safety of RXC004 monotherapy and in combination with pembrolizumab in advanced solid tumours that have progressed following SoC treatment.
Detailed Description
This Phase II, modular, open label, multicentre study initially opened with ring finger protein 43 (RNF43) loss of function (LoF) mutation-positive pancreatic ductal adenocarcinoma (PDAC) (Module 1) a...
Eligibility Criteria
Inclusion
- Core
- At least one lesion that is measurable by RECIST 1.1 at baseline (within 6 weeks 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 from the time of treatment initiation, 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 progression
- Karnofsky performance status ≥70.
- Module 2 and Module 3 (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 progression
- ECOG status 0 or 1.
- Core
Exclusion
- 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
- 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 or live-attenuated vaccines against infectious diseases (e.g., influenza nasal spray, varicella) within 4 weeks (28 days) of initiation of study treatment
- Mean resting corrected QTcF \>470 ms, obtained from triplicate ECGs performed at screening.
- There are no exclusion criteria specific to Modules 1 and 2.
- Module 3 Specific
Key Trial Info
Start Date :
December 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04907851
Start Date
December 10 2021
End Date
November 30 2023
Last Update
March 17 2025
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Wollongong Hospital
Wollongong, New South Wales, Australia, 2500
2
The Alfred Hospital - Alfred Health
Melbourne, Victoria, Australia, 3304
3
Cambridge University Hospital NHS Foundation Trust
Cambridge, United Kingdom, CB2 0XY
4
Beatson West of Scotland Cancer Care
Glasgow, United Kingdom, G12 0YN