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

  • STATUS
    Recruiting
  • End date
    Jun 10, 2023
  • participants needed
    40
  • sponsor
    Redx Pharma Plc
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Updated on 13 May 2022
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Summary

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

Description

This Phase II, modular, open label, multicentre study will initially open with ring finger protein 43 (RNF43) loss of function (LoF) mutation-positive pancreatic ductal adenocarcinoma (PDAC) (Module 1) and biliary tract cancer (BTC) (Module 2) modules. 15 evaluable patients will be enrolled in each module.

The primary objective of the study is to assess the preliminary efficacy of RXC004 in each module in terms of progression free survival (PFS) at 6 months. Following radiological progression, patients will be followed-up for survival.

Details
Condition Advanced Solid Tumours
Treatment Denosumab, RXC004
Clinical Study IdentifierNCT04907851
SponsorRedx Pharma Plc
Last Modified on13 May 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 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 (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

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 3 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 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
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