UC Davis Health Clinical Studies

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

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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

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

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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

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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

A Study of Experimental Medicine Atezolizumab for Non-Small Cell Lung Cancer

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This study will test the safety and effectiveness of experimental treatment with atezolizumab. It will be compared to a placebo (inactive treatment). Participants will be randomly assigned to one of the two treatment groups: -Experimental atezolizumab -Placebo Neither the study doctor nor the participants will know which treatment they receive. Both treatment groups will be combined with platinum-based chemotherapy. The study will involve participants with non-small cell lung cancer (NSCLC). The second part of the study will be "open-label." Participants will know which treatment they are receiving in the second part of the study.

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