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

Sponsor
Redx Pharma Ltd
Study ID
NCT04907851
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Solid Tumours

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RXC004 — DRUG
    RXC004 will be administered orally, 2 mg QD; Dose Formulation: 0.5 mg or 1 mg capsules.
  • RXC004 — DRUG
    RXC004 will be administered orally, 2 mg QD (Cohort 1, Module 2) and 1 mg QD (Cohort 2, Module 2); Dose Formulation: 0.5 mg or 1 mg capsules.
  • RXC004 — DRUG
    RXC004 will be administered orally, 1.5 mg QD; Dose Formulation: 0.5 mg or 1 mg capsules.
  • Denosumab — BIOLOGICAL
    Denosumab will be administered via subcutaneous (SC) injection, 120 mg once every month; Use: Prophylactic
  • pembrolizumab — BIOLOGICAL
    Pembrolizumab will be administered via intravenous infusion, 400 mg dose once every 6 weeks

Study Details

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.

Key Dates

Start date
Dec 10, 2021
Status verified
Feb 2025
Primary completion
Nov 30, 2023
Completion
Nov 30, 2023

Study Design

Enrollment
45 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1 - RNF43 Mutated Advanced (unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)
    Patients (Karnofsky performance status ≥70) will be recruited and dosed with RXC004 (2 mg once daily \[QD\], orally) within 6 weeks of progression following 1st line SoC treatment.
  • Experimental: Module 2 -Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)
    Patients (Eastern Cooperative Oncology Group \[ECOG\] performance status 0-1) will be recruited and dosed with RXC004 within 6 weeks of progression, following 1st line SoC treatment.
  • Experimental: Module 3-Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy
    Patients (ECOG performance status 0-1) will be recruited and dosed with RXC004 (1.5 mg QD, orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression, following 1st line Soc treatment.

Primary Outcome Measure

Monotherapy (Modules 1 and 2): Progression Free Survival Rate at 6 Months [ Time Frame: At 6 months ]

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