Study to Evaluate the Safety and Tolerability of RXC004 in Advanced Malignancies

Sponsor
Redx Pharma Ltd
Study ID
NCT03447470
Phase
PHASE1
Status
Completed

Conditions

  • Cancer
  • Solid Tumor

Eligibility Criteria

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

Interventions

  • RXC004 — DRUG
    RXC004 is taken orally, inhibits porcupine (PORCN) and interacts with the wnt signalling pathway.
  • Nivolumab — DRUG
    RXC004 is taken orally, inhibits porcupine (PORCN) and interacts with the wnt signalling pathway. Nivolumab is a fully human monoclonal immunoglobulin G4 antibody to PD-1

Study Details

The purpose of this study is to determine the safety and tolerability of RXC004 as monotherapy and in combination with Nivolumab in patients with advanced malignancies. In order to define the doses and schedules for further clinical evaluation.

Key Dates

Start date
Mar 18, 2019
Status verified
Dec 2024
Primary completion
Sep 29, 2023
Completion
Sep 29, 2023

Study Design

Enrollment
46 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
    Patients were given 0.5 mg RXC004 and monitored for Dose Limiting Toxicities.
  • Experimental: Module 2 Arm 1 - RXC004 (1.0 mg) plus Nivolumab
    Patients were given 1.0 mg RXC004 in combination with a standard dose of Nivolumab and monitored for Dose Limiting Toxicities.
  • Experimental: Module 3 - Intermittent schedules of monotherapy RXC004
    Patients were given 2.0 mg RXC004. The patients were treated for 2 weeks at the same dose, followed by 1 week off for a 21 day cycle.
  • Experimental: Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
    Patients were given 1.0 mg RXC004 and monitored for Dose Limiting Toxicities.
  • Experimental: Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
    Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
  • Experimental: Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
    Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
  • Experimental: Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
    Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
  • Experimental: Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
    Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
  • Experimental: Module 2 Arm 2 - RXC004 (1.5 mg) plus Nivolumab
    Patients were given 1.5 mg RXC004 in combination with a standard dose of Nivolumab and monitored for Dose Limiting Toxicities.

Primary Outcome Measure

Module 1 - Safety and Tolerability of RXC004 by Assessment of Whether Any Dose Limiting Toxicities (DLT) Arise From First Dose Until the End of 21 Days of Continuous Dosing: [ Time Frame: AE data was collected after each cycle and until 30-day follow-up visit after study exit. The DLT period were assessed from the first dose until the end of 21 days of continuous dosing in each cycle until a Maximum Tolerated Dose (MTD) was identified. ]

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