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 1143 with nivolumab in specific advanced solid tumors
Debiopharm International is conducting an open-label two-part Phase 1b/2 trial in male and female patients with either small cell lung cancer, squamous cell carcinoma of the head and neck, selected gastrointestinal or gynecologic cancers with specific genetic alterations. Tumors with these genetic alterations may respond better to this study treatment. To be eligible, patients must have received at least one prior standard chemotherapy or have no established standard therapeutic alternatives. In addition, patients must have progressed during prior immuno-oncology treatment.
The purpose of Part B is to evaluate whether Debio 1143 combined with nivolumab leads to efficient shrinkage of the tumor in patients with different types of cancer and to determine how safe it is.
Debio 1143 is an investigational medicinal product. Nivolumab is a monoclonal antibody that specifically blocks a target in the body called PD-1 and stimulates the immune system to fight cancer cells.
Debio 1143 is administered orally once daily for 10 consecutive days every 2 weeks. Nivolumab is administered by infusion every 2 weeks.
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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
Clinical trial of Debio 0123 in combination with carboplatin and etoposide in patients with small cell lung cancer
The Debio 0123-SCLC-104 study is an open-label, multi-center study evaluating an experimental drug (Debio 0123) administered in combination with common chemotherapeutic agents called carboplatin and etoposide, in patients with small cell lung cancer that recurred or progressed after previous standard platinum-based therapy.
The Debio 0123-SCLC-104 study is divided into 2 parts.
In Part 1 – Dose Escalation
Debio 0123 is given at different doses. The objective is to find the best dose when combined with carboplatin and etoposide.
In Part 2 – Dose Expansion
the objective will be to confirm the dose determined in Part 1. This will be done by assessing the side effects of the combination of carboplatin, etoposide and Debio 0123 and its possible effects on the tumor. Part 2 will also explore the way the drug works and is processed in the human body.
Part 1 inclusion criteria
- You have been diagnosed with small cell lung cancer.
- Your disease has been recurring or progressing after at least 45 days since platinum-based therapy.
- You are able and willing to adhere to study plan and procedures (including biopsies) and use effective contraceptive methods.
Part 2 inclusion criteria
- You have been diagnosed with small cell lung cancer
- Your disease has been recurring or progressing after at least 90 days since platinum-based therapy.
- You are able and willing to adhere to study plan and procedures (including biopsies) and use effective contraceptive methods
About Debio 0123
Cancer cells generally grow quickly and accumulate DNA damage over time. Too much DNA damage could cause the cells to die when they divide to form new cells. Therefore, many cancer cells take advantage of cell machinery, which allows time to repair this damage, so they can continue to multiply and survive.
The drug being investigated in this study, Debio 0123, prevents the cells from repairing their damaged DNA. As such, it is believed that it may help kill cancer cells and reduce tumor size.
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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.