In short
PTT-4256 is an investigational substance being studied in one clinical trial for people with solid tumours. The trial, known as RAISIC-1, is a Phase 1/2 study with a planned enrollment of 150 participants. It is testing PTT-4256 both on its own and in combination with an approved PD-1/PD-L1 inhibitor to determine safety and tolerability.
Key points
- PTT-4256 is being tested in solid tumours in a Phase 1/2 trial.
- The trial is authorised and plans to enroll 150 participants.
- PTT-4256 is given by oral use (by mouth).
- The study tests PTT-4256 as a monotherapy and in combination with a PD-1/PD-L1 inhibitor.
- The main outcome measures safety and tolerability, including side effects and serious side effects.
- The trial is called RAISIC-1 and is an open-label dose-finding study.
What is PTT-4256?
PTT-4256 is an investigational substance being studied in people with solid tumours. It is not yet an authorised medicine. The substance is given by mouth (oral use). The trial record does not describe the chemical class or mechanism of action of PTT-4256.
How does PTT-4256 work?
The trial record does not state how PTT-4256 works or what molecular target it acts on. The study is designed to find out whether PTT-4256 is safe and tolerable, both on its own and when combined with an approved inhibitor of PD-1/PD-L1. PD-1 and PD-L1 are proteins involved in the immune system's ability to recognise and attack cancer cells; inhibitors of these proteins are a type of immunotherapy.
Which conditions is PTT-4256 being studied for?
- Solid tumours — the trial includes participants with specified tumour types, though the exact tumour types are not listed in the registry record.
How is PTT-4256 given?
PTT-4256 is given by oral use, meaning it is taken by mouth. The trial also includes a comparison arm with OPDIVO (nivolumab), a 10 mg/mL concentrate for solution for infusion, given by infusion into a vein. The specific dose of PTT-4256 is not reported in the registry record; the study is a dose-finding study, meaning different doses are being tested.
What do the clinical trials show?
There is one clinical trial of PTT-4256 registered: an open-label, dose-finding Phase 1/2 study called RAISIC-1. The trial is authorised and plans to enroll 150 participants. It is an interventional study, meaning participants receive the treatment as part of the research.
The primary outcome being measured is the incidence, nature, and severity of adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs). In plain words, the study is recording how often side effects occur, what they are, and how severe they are. The study is testing PTT-4256 as a monotherapy (on its own) and in combination with an approved PD-1/PD-L1 inhibitor.
The trial is open-label, meaning both the researchers and the participants know which treatment is being given. It is a dose-finding study, so one of its goals is to identify the most appropriate dose for further research.
What side effects are known?
The registry record for the RAISIC-1 trial does not list specific side effects of PTT-4256. The primary purpose of the ongoing study is to measure the incidence, nature, and severity of adverse events, serious adverse events, and treatment-emergent adverse events. No further information on side effects is available from the sources provided.