UC Davis Health Clinical Studies

A Study of Experimental RVT-1201 for Pulmonary Arterial Hypertension (ELEVATE 1)

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Pulmonary Arterial Hypertension, also known as PAH, is a serious, and rare, disease. It causes shortness of breath with activity, fatigue and weakness. Other symptoms may include chest pain, dizziness and swelling of the ankles and feet. These symptoms are caused by a decrease in oxygen-rich blood flow that is sent from the lungs to the rest of the body. In patients with PAH, the blood vessels in the lung are diseased and become thick and narrow. This causes an increase in the pressure that your heart must pump against to push blood through your lungs. There is currently no cure for PAH, but there are treatments available that help improve symptoms. Standard treatment for PAH includes the use of drugs known as vasodilators. These act to: - open the blood vessels in the lungs, - improve blood flow through the lungs and - reduce the higher than normal pressures in the blood vessels of the lungs. They may reduce your symptoms and slow the disease from getting worse. In order to be able to participate in this study you will have to be already taking at least one of these vasodilator drugs. In patients with PAH, vasodilator drugs are sometimes combined with diuretics (also called “water pills”). These remove the excess fluid that tends to build up in the body in patients with PAH. Sometimes, vasodilator drugs are also combined with anticoagulants. These are drugs which affect how your blood clots and/or oxygen support. There are experimental (not approved) drugs that are being studied in clinical trials in patients with PAH. RVT 1201 is one of those experimental drugs. It is being tested to understand if it may be a useful addition to treatment for patients who are already taking vasodilators for their PAH symptoms. Before this study, RVT-1201 has not been given to any patients with PAH. The researchers who are conducting the study hope to learn several important things from this study: · To understand the side effects of RVT-1201 in patients with PAH and to see if they are similar to the side effects experienced by healthy volunteers · To better understand how RVT-1201 impacts serotonin levels in patients with PAH. Serotonin is a substance that occurs naturally in your body. It is mainly found in your intestines but also in your central nervous system and appears to affect and/or regulate a number of body functions. Increased serotonin levels in the lung are thought to be one of the potential causes of PAH · To study how the body processes RVT-1201 · To see if RVT-1201 may improve your PAH symptoms (for example, to see if it improves your shortness of breath or your ability to exercise)

Drug study, Phase 2
Any, age 18 to 75 years old

A Study of Experimental ABBV-011 Alone and Combined With ABBV-181 for Relapsed or Refractory Small Cell Lung Cancer

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SC-011 is an experimental drug. Experimental means the drug being tested has not been approved by the FDA for the treatment of small cell lung cancer. SC-011 is a type of drug called an antibody-drug conjugate (ADC). SC-011 is made up of a monoclonal antibody (a type of human protein) that is linked to a form of chemotherapy. A monoclonal antibody is a type of protein made in the laboratory that can attach to substances in the body, in this instance, cancer cells. The monoclonal antibody specifically binds to a protein called seizure-related homolog 6 (SEZ6). This can be found on the surface of certain cancer cells. After binding, SC-011 enters the cell and the chemotherapy becomes active. ADCs are designed to try and more precisely deliver chemotherapy to cancer cells. This type of targeted therapy may have fewer side effects. It may be more effective than a treatment that is not directed toward a specific cancer target. Not all advanced cancer tumors produce the SEZ6 protein. If your tumor does not produce SEZ6, it is thought that it is less likely that SC-011 will benefit you. To determine if you express the SEZ6 protein, we will request a tissue sample of your tumor. Depending on which part of the study you participate in (such as Dose Escalation or Dose Expansion), the results of the test will be available to you.

Drug study, Phase 1
Any, age 18 years or older

A Study Testing the Long-term Safety and Effectiveness of Experimental VX-445 Combination Therapy in Cystic Fibrosis

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This study is being done to learn more about the effectiveness and safety of an experimental combination of medicines. The combination of VX-445/tezacaftor (TEZ)/ivacaftor (IVA) will be tested in patients with cystic fibrosis. • The triple combination VX-445/TEZ/IVA is an experimental drug. This means the study drug is not approved by the FDA. It is still being tested for safety and effectiveness. • TEZ in combination with IVA (TEZ/IVA) is approved in certain countries for use in some people living with CF who are 12 years or older. • IVA is approved in a number of countries globally, for use in some people living with CF who are as young as 6 months, depending on the country. If you would like to know in which countries or for which people living with CF TEZ/IVA or IVA has been approved, please ask your Study Doctor.

Drug study, Phase 3
Any, age 12 years or older

A Study of Experimental VX-445 Combination Therapy for Cystic Fibrosis with Genetic Mutations (F508del and Gating or Residual)

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This study will test the effectiveness and safety of the experimental medicine VX-445. It will be combined with TEZ and IVA in subjects with cystic fibrosis (CF). • The triple combination VX-445/TEZ/IVA is an experimental drug. This means the Study Drug is not approved by the FDA and is still being tested for safety and effectiveness. • TEZ combined with IVA (TEZ/IVA) is approved in some countries for use in some people living with CF who are 12 years or older. • IVA, the third Study Drug used in this study, is approved in a number of countries globally. It is used for people living with CF who are as young as 6 months, depending on the country. • Please ask the Study Doctor if you would like to know in which countries or for which people living with CF TEZ/IVA or IVA has been approved.

Drug study, Phase 3
Any, age 12 years or older

A Study of the Safety and Activity of Experimental TRK-250 for Idiopathic Pulmonary Fibrosis

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Idiopathic pulmonary fibrosis (IPF) is a serious and progressive disease. It results in scarring of lungs for an unknown reason. This disease worsens over time, which makes it more difficult for people diagnosed with this disease to breathe and get enough oxygen. Currently, there is no cure for IPF. There are two known and approved medicines available for treatment to slow disease progression. There is evidence that shows that a specific growth factor (a protein that can start growth processes inside your cells) is related to the scarring, or fibrosis, that happens in lungs affected by IPF. The drug being studied here is called experimental TRK-250. It is designed to affect this protein. In studies done on monkeys, the study drug stopped this protein from working. This research aims to see the effect this study drug has in humans. The study drug is an experimental drug that has not been used in humans before, and is not approved by the Food and Drug Administration (FDA) to treat IPF. This study seeks to find more information on its safety and how your body might tolerate this new drug.

Drug study, Phase 1
Any, age 40 to 80 years old

A Study to Test The Safety and Effectiveness of Experimental GLPG1690 for Idiopathic Pulmonary Fibrosis (IPF)

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You are being asked to take part in this clinical research study because you have idiopathic pulmonary fibrosis (IPF). Pulmonary fibrosis is a disease in which tissue deep in the lungs becomes thick and stiff, or scarred, over time. Fibrosis is the formation of scar tissue. As the lung tissue thickens, the lungs cannot properly expand. This might lead to difficulties in moving oxygen into the bloodstream and is measured by lung function tests. You might have symptoms such as shortness of breath, tiredness, or other symptoms. This is caused by scarring and the decline of your lung function. When a cause of this fibrosis is not found, it is called “idiopathic”. Idiopathic pulmonary fibrosis is a progressive disease that mainly affects elderly people. Treatment for IPF has been available for several years and is able to slow down the decline in lung function. However, there is still a need to further improve the lung function with other drugs. These treatments for IPF are called nintedanib and pirfenidone. Both nintedanib and pirfenidone can be taken for IPF. One new drug being investigated for the treatment of IPF is experimental GLPG1690. It has been described that subjects with IPF have increased levels of autotaxin. This is a substance made by the body which could affect inflammation and scarring in the lungs. It is being studied whether GLPG1690 can safely reduce autotaxin levels in the lungs that occur in people with IPF. This would therefore affect the progression of the disease. The main purpose of this study is to see how experimental GLPG1690 works. It will be given together with your current standard treatment on your lung function and IPF disease in general. The study will also look at how well GLPG1690 is tolerated (for example if you get any side effects while on study drug).

Drug study, Phase 3
Any, age 40 years or older

Experimental [18F]-AraG to Detect T-Cell Activation in Advanced Non-small Cell Lung Cancer Patients Undergoing Immunotherapy

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We invite you to take part in a research study because you have been diagnosed with non-small cell lung cancer. As part of your treatment, you will be undergoing treatment with a type of therapy called immunotherapy. Researchers have developed a new drug to aid in the detection of cancer, called a “radiotracer.” It attaches to immune cells directed at the cancer. Using a special camera, called a “positron emission tomography” or “PET” scanner, these radiotracers are visible. We hope this new radiotracer will help us learn how cancer in the body responds to immunotherapy. This new radiotracer is called experimental "[18F]F-AraG."

Drug study, Phase 1
Any, age 18 years or older

A Study of Experimental Ibrexafungerp (SCY-078) for Invasive Pulmonary Aspergillosis (serious fungal infection)

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The purpose of this research is to see how well an experimental drug, SCY078, works. It will be tested in people with a fungal disease called acute Invasive Pulmonary Aspergillosis. Invasive Pulmonary Aspergillosis is a serious infection. It usually affects people who have a weakened immune system such as those receiving treatments for: - blood cancers (hematologic malignancies), - bone marrow (hematopoietic cell) transplantation, or - liver (solid organ) transplantation. You are invited to be in this study because you have been diagnosed with Invasive Pulmonary Aspergillosis. Your doctor will need to run tests on your blood to confirm if your infection is likely caused by Aspergillus. A fungal disease (like Invasive Pulmonary Aspergillosis) is an infection caused by a fungus, or mold. Participation in this study will involve a screening period, where you will have several tests to check whether the study is right for you. During the treatment period, you will receive the study drug and have tests and assessments done. You will receive study treatment for a recommended minimum of 6 weeks and a maximum of 13 weeks. You will have one more follow-up visit 6 weeks after you finish treatment to assess if you have had a recurrence and do a final safety assessment.

Drug study, Phase 2
Any, age 18 years or older
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