A ‘clinical trial’ is a research study in which people agree to test a potential new treatment to prevent 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 existing treatments.
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.
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.