A Modular, Multi-arm, Multi-part, Phase 1/2a study to evaluate RXC004
Research type
Research Study
Full title
A Modular, Multi-Arm, Multi-Part, Phase 1/2a, Adaptive Design Study To Evaluate The Safety And Tolerability Of RXC004, Alone And In Combination With Anti-Cancer Treatments, In Patients With Advanced Malignancies
IRAS ID
222362
Contact name
Natalie Cook
Contact email
Sponsor organisation
Redx Pharma plc
Eudract number
2017-000720-98
Duration of Study in the UK
2 years, 1 months, 24 days
Research summary
The study is a first in human study (FiH) using the investigational drug RXC004 for the treatment of advanced malignancies. The drug will be given orally as a single drug at increasing doses to define the acceptable dose. The study module will start with the first dose group of participants being given daily 10mg.
The study will consist of up to 3 modules with parts A and parts B. The focus for now is on Module 1 Part A.
This is an open label Phase 1/2a dose escalation study to assess the safety, tolerability, the way the body absorbs, distributes and gets rid of RXC004 in patients diagnosed to have advanced solid tumours. Eligible participants will be enrolled and treated with increasing doses of the study drug RXC004 given as an oral capsule dose, while being closely monitored for safety.
Individual participants will only receive one dose strength of RXC004. This process of increasing the dose, continues until a dose is reached that is generally not tolerated by the participants within that dose group. The highest dose that is tolerated is called the MTD (maximum tolerated dose).
After each dose level during the dose escalation phase of the study, a safety review committee (SRC) will evaluate the safety and tolerability and pharmacokinetics (data about how the drug affects the body) of RXC004 to decide the next dose and also whether once daily dosing should be changed to a more or less frequent dosing schedule.
The purpose of this study module is to determine how safe and tolerable the investigational drug, RXC004. The study module will also evaluate the activity of the study drug at increasing doses to define an acceptable dose.
Approximately 50 patients will participate and will be dosed for a maximum of 8 three-weekly treatment cycles of therapy.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
17/WM/0155
Date of REC Opinion
16 Jun 2017
REC opinion
Further Information Favourable Opinion