UC Davis Health Clinical Studies

A Study of the Experimental Medicine Alvelestat (MPH966) for Chronic Obstructive Pulmonary Disease (COPD)

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

Alpha-1 antitrypsin (α1AT) is a protein. It is made in the liver, circulates in the bloodstream, and protects lung tissue from an enzyme called elastase. Elastase is released by your white blood cells (a type of cell in your blood that helps fight infections). Elastase fights infection in the lungs, but can attack healthy lung tissue if not controlled by α1AT. This study is being done to see if the study drug, alvelestat (MPH966), can inhibit the activity of elastase. Alvelestat is an experimental drug which has not been approved by the FDA.

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

A Study Evaluating the Long-term Safety and Effectiveness of Experimental VX-445 Combination Therapy for Cystic Fibrosis (CF)

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

The purpose of this research study is to learn more about the safety and effectiveness of VX-445. It will be used in combination with TEZ and IVA in patients with cystic fibrosis (CF). · The triple combination VX-445/TEZ/IVA is an experimental drug. “Experimental” means the 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 as young as 2 years old. 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 the Safety and Effectiveness of Experimental Ralinepag for Patients With Pulmonary Arterial Hypertension

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

This study will test an experimental medication called Ralinepag. It will be used in the treatment of pulmonary arterial hypertension (PAH). Ralinepag has not been approved by the FDA and is not available by prescription. Ralinepag is designed to activate the prostacyclin receptor. The prostacyclin receptor is a protein found on cells of blood vessels. A naturally occurring substance called prostacyclin attaches to it. In patients with PAH, reduced activity of the prostacyclin receptors can cause the blood vessels in the lungs to become narrow. This it harder for the blood to flow. By increasing the activity of prostacyclin receptors, we hope that Ralinepag may improve blood flow to the lungs. This may improve symptoms of PAH (shortness of breath while exercising, dizziness, high blood pressure). We are doing this research study to test whether the study drug provides the expected benefits to patients who take it. This study is being done at UC Davis Health and at other sites around the U.S.

Drug study, Phase 3
Any, age 18 to 75 years old

A Study of Experimental Fenretinide (LAU-7b) for Cystic Fibrosis in Adults

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

Cystic fibrosis (CF) is a multi-system disease affecting the respiratory tract. It involves the lungs, nose, and sinuses, pancreas, liver, sweat glands, and reproductive organs. The lungs often experience ongoing infection (usually with bacteria called Pseudomonas aeruginosa). It sustains out-of-control inflammation that results in irreversible damage. This is a research study of an experimental drug called fenretinide (LAU-7b). Experimental means that this drug has not been approved by the U.S. Food and Drug Administration (FDA). The study drug (LAU-7b) is a derivative of Vitamin A. The FDA has approved the testing of fenretinide in this study. Researchers hope that treatment with fenretinide will preserve lung function. We hope it will reduce the persistent inflammation in the lung. We also hope it improves the lung's capacity to defend against bacteria such as Pseudomonas aeruginosa. The main goals of this study are to determine if fenretinide: Is safe and well tolerated Improves lung function as measured by spirometry. Spirometry is a routinely performed test to measure lung function.

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

A Study of the Safety and Effectiveness of the Experimental Medicine Tisotumab Vedotin for Solid Tumors

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

We are doing this study to find out if tisotumab vedotin treats solid tumor cancer. We want to see if patients with your kind of cancer respond to the drug. We want to see how long it takes patients to respond to tisotumab vedotin and how long the response lasts. We also want to learn more about any side effects patients experience during treatment with tisotumab vedotin. Tisotumab vedotin is a type of drug called an antibody drug conjugate or ADC. ADCs usually have 2 parts. ● Antibody: Antibodies are part of your immune system. Usually, they help protect you from getting sick. In tisotumab vedotin, we are using an antibody that is designed to find and stick to the solid tumor cancer cells in your body. ● Drug: the part of the ADC that kills cells. The cell-killing part of tisotumab vedotin is a drug called MMAE. In tisotumab vedotin, the antibody part is designed to stick to cancer cells so that the drug part can kill them. It may also stick to some non-cancer cells in your body. We are asking patients with four types of solid tumor cancer to take part in this study. The four types are colorectal cancer, squamous non-small cell lung cancer (NSCLC), pancreatic cancer, and squamous cell cancer of the head and neck (SCCHN). More than 200 people with cancer have already been given tisotumab vedotin in research studies. These studies tested different doses of tisotumab vedotin to see if it is safe in people. They also tested how well tisotumab vedotin works to treat cancer.

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

A Study of Experimental Combination Therapy, Surgery With or Without Radiation Therapy for Mesothelioma

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

You are being asked to take part in this study because you have mesothelioma. People who are not in a study are usually treated with either drugs, and/or surgery, and/or radiation. One of the standard treatment options for your type of cancer is cisplatin and pemetrexed. Atezolizumab is an experimental cancer drug. It is approved for the treatment of patients with bladder cancer and lung cancer. This study is being done to test the safety of giving all three drugs together. The study team will test any good and bad effects of taking atezolizumab after surgery and/or radiation. This study uses a combination of drugs (cisplatin, pemetrexed) that have already been FDA-approved. They will be given by vein. The purpose of this study is to test the safety of giving one drug, atezolizumab, along with cisplatin and pemetrexed, before surgery. As well as giving atezolizumab after surgery by vein.

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

A Study of Experimental Combination Treatment With Osimertinib and Navitoclax For EGFR-Positive Non-small Cell Lung Cancer

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

This study uses a combination of drugs called AZD9291 (Osimertinib) and navitoclax. This is an investigational approach for treating lung cancer. These medications have previously been given to lung cancer patients separately. They have not been studied in combination. The purpose of this study is to test whether giving these two drugs together is safe. AZD9291 is an EGFR inhibitor which has been shown in prior studies to be safe and effective for lung cancer with EGFR mutations. Navitoclax is an inhibitor of certain proteins believed to play a key role in promoting the survival of cancer cells. AZD9291 (Osimertinib, Tagrisso) is approved for metastatic non-small cell lung cancer (NSCLC). Specifically, NSCLC that carries a specific gene mutation in EGFR, called T790M. This T790M mutation causes resistance to some kinds of EGFR inhibitors, but can be treated with AZD9291. Navitoclax is not FDA approved for any indication.

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

A Study of the Safety, Tolerability and Effectiveness of the Experimental Medicine PB1046 for Pulmonary Arterial Hypertension

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

This is a research study involving an investigational drug called PB1046. "Investigational" means that the drug is not yet approved by the FDA. The study drug contains an active ingredient similar to a protein called vasoactive intestinal peptide (VIP). The VIP protein is normally found in the body. The change made to the natural protein helps to protect the protein from breaking down too quickly. Scientific sources state that the amount of VIP may be lower in people with pulmonary arterial hypertension (PAH). The purpose of this study is to see how well participants with PAH tolerate the study drug. We will also study how much of the study drug is absorbed into the bloodstream and how long it stays in the blood stream (called pharmacokinetics). The study will also see whether your body makes antibodies against the study drug. Antibodies are proteins produced by the body's immune system. They are usually found in the blood that help protect our bodies from harm by finding and destroying invaders, like bacteria and viruses. They can also cause harm when they find other proteins that are not normally in the body like the study drug. These antibodies can make the study drug, or the natural VIP found in our bodies not work as well or not at all. In addition, the study will look at the effect of the study drug on special markers in the blood that are related to PAH.

Drug study, Phase 2
Any, age 18 to 79 years old

A Study of the Safety and Effectiveness of Experimental Inhaled Treprostinil For Pulmonary Hypertension due to COPD

Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!

This study involves research about experimental inhaled treprostinil. This study will test its effectiveness in improving exercise ability in patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD). Its effects will be compared to an inactive solution, or placebo. A placebo looks like the study drug, but does not contain the study drug’s active ingredient(s). Inhaled treprostinil (brand name Tyvaso®) is FDA approved for other diseases. In this study, inhaled treprostinil is considered to be an investigational (not approved by the FDA) treatment for PH-COPD. Inhaled treprostinil will be given by a handheld inhalation device. The "study nebulizer" is called the Tyvaso® Inhalation System.

Drug study, Phase 3
Any, age 18 years or older
Loading