Study on the Safety and Tolerability of TransCon IL-2 β/γ Alone or with Pembrolizumab and/or Chemotherapy in Adults with Advanced Solid Tumors
Sponsor: Ascendis Pharma Oncology Division A/S
ClinicalTrials ID:NCT05081609
This clinical trial is testing a new drug, TransCon IL-2 β/γ, to see if it is safe and well-tolerated when used alone or with other treatments in adults with advanced solid tumors. The study aims to find the best dose and understand how the drug works in the body.
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Program Overview
TransCon IL-2 β/γ is an experimental drug being tested for treating advanced solid tumors that have spread or cannot be removed by surgery. This is the first time it is being tested in humans. The study will explore different doses of TransCon IL-2 β/γ, both on its own and in combination with other treatments, to see how safe it is and how well it works. The unique design of TransCon IL-2 β/γ may improve the effectiveness and safety of current IL-2 therapies.
Description
IL-2 is a protein that helps the immune system by increasing the number of cells that can attack cancer. TransCon IL-2 β/γ is designed to be a long-lasting form of IL-2, which may make it safer and more effective. This study will test TransCon IL-2 β/γ in adults with advanced solid tumors to see if it can help control the cancer. Participants will receive the drug either alone or with other treatments like pembrolizumab or chemotherapy. The study will monitor participants for side effects and measure how well the treatment works against the cancer.
Eligibility Criteria
Inclusion Criteria
- Must be at least 18 years old.
- Must have good organ function as shown by medical tests.
- Must have a life expectancy of more than 12 weeks.
- Must agree to use effective birth control if they are of childbearing potential.
- Must have a confirmed diagnosis of advanced solid tumors that cannot be cured with surgery or radiation.
- Must have a performance status score of 0, 1, or 2, indicating they are fully active or have some limitations but can still care for themselves.
- Must have stopped certain previous cancer treatments at least 4 weeks before starting the study and show disease progression.
- Any side effects from previous immunotherapy must be resolved to a mild level or back to baseline.
- For certain parts of the study, the cancer must be completely removable by surgery.
Exclusion Criteria
- Have cancer that has spread to the brain or spinal cord and is causing symptoms.
- Have active autoimmune diseases, unless well controlled with hormone replacement.
- Have any uncontrolled infections.
- Have significant heart disease.
- Have a prolonged QT interval on an ECG, which is a measure of heart rhythm.
- Test positive for HIV or have active hepatitis B or C.
- Have allergies to any of the study treatments.
- Have been previously treated with IL-2 or similar drugs for certain cancers.
- Are on systemic immunosuppressive treatment, except for certain steroid tapers.
- Have received a live vaccine within 4 weeks before starting the study.
- Have had other cancer treatments within 4 weeks before starting the study.
- Have had other active cancers within the last 2 years.
- Are pregnant or breastfeeding.
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