Clinical trials
A ‘clinical trial’ is a research study in which a potential new treatment is investigated to prevent, cure or improve a disease or medical condition. A clinical trial also looks at how participants react to the potential new treatment and if any unwanted effects occur. This helps to determine if the new investigational treatment works, is safe, and is better than those that are already available. Many clinical trials also compare existing treatments or test new ways to use or combine with existing treatments.
All new drugs must be tested in clinical trials before they can be prescribed to patients. Without people taking part in these research studies, we would have no new drugs to help others with their condition.
Clinical trial of Debio 1562M in patients with Acute Myeloid Leukemia
The Debio 1562M-101 trial is an open-label Definition Open-label is a type of medical study where both the doctors and the participants know which treatment is being given , multicenter trial evaluating an experimental drug (Debio 1562M) administered in patients with recurrent or treatment-resistant acute myeloid leukemia (AML).
Debio 1562M is a new type of medicine called an antibody drug conjugate (ADC), that combines a targeted substance called an antibody with a drug to specifically kill cancer cells. This will be the first time that Debio 1562M is administered to people. Laboratory tests have shown that Debio 1562M is safe and could potentially help in the treatment of acute myeloid leukemia and myelodysplastic syndromes (MDS). The Debio 1562M-101 study is divided into 3 parts:
Phase 1 – Dose Escalation
The objective is to evaluate Debio 1562M at different doses to identify the highest safe dose to be tested further in the next phase.
Phase 1 – Dose Optimization
The objective is to test the optimal dose identified during the Phase 1 – Dose Escalation and recommend the best dose and/or dosing schedule to be tested in Phase 2.
Phase 2
The objective is to test how well the recommended dose and/or dosing schedule works in patients with recurrent/treatment-resistant AML.
You may be able to take part if:
- You are willing to adhere to study plan and procedures and use effective contraceptive methods.
- You have been diagnosed with recurrent/treatment-resistant AML (or recurrent/treatment-resistant MDS, for Phase 1 – Dose Escalation only)
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Phases
When a potential new medication is being developed, it is first tested in a laboratory setting. If the results are positive, the drug may enter a clinical trial program. This means that it will be tested in humans in several ‘phases’ of study.
Phase I = Safety evaluation. The very first administration in humans, typically carried out in a small group of healthy volunteers to assess if the drug is safe.
Phase II = Efficacy evaluation. The first trials in patients with the intended disease to check if the drug works efficiently and if there are any unwanted side effects.
Phase III = Confirming findings. Trials in large numbers of patients that generally compare the drug to the best treatments available.
_Phases
- P
- Ⅰ
- Ⅱ
- Ⅲ
- M
Talk with your medical doctor
If you are interested in participating in an upcoming clinical trial (can be also referred to as a clinical study), ask your doctor if a clinical trial might be right for you. Your doctor knows both you and your health history, which is invaluable in making this decision. Your doctor can help you gather the information needed to locate a trial and help you identify what questions might be important to ask the clinical trial doctor before deciding to participate.