UC Davis Health Clinical Studies

A Study of Experimental TTX-030 With or Without Immunotherapy or Chemotherapy for Advanced Cancers

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You are invited to take part in a voluntary research study to test an investigational drug called TTX-030. It will be given alone or in combination with either one of the FDA-approved drugs: Pembrolizumab, Docetaxel, or Gemcitabine and Nab-paclitaxel. The purpose of this research study is to find out the highest dose of TTX-030 that can be given to subjects. We hope to learn its side effects, the level of investigational drug in your blood and how the body gets rid of the drug after dosing. This study involves 4 treatment groups (arms). An ARM of a research study is a group of patients receiving a specific treatment. Treatment visits will involve Arms 1, 2, 3, which is a 21- day cycle, and Arm 4, a 28-day cycle. One cycle is 21 or 28 days, which is equivalent to 3 or 4 weeks, depending which Arm you participate in. You will visit the study site 4-5 times during Cycle 1, 2 times during Cycle 2, 1-2 times during Cycle 3, and 1 time for each following cycle.

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

Experimental Combination Treatment For Chemotherapy-Refractory (treatment resistant) Metastatic Pancreatic Cancer

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This is a research study for cancer treatment resistant metastatic pancreatic cancer. It will test the safety and effectiveness of an experimental combination treatment. The combination treatment used in this study includes nivolumab, SD-101 and radiation therapy. The study team hopes to learn how patients with metastatic pancreatic cancer respond to this combination. The study drug Nivolumab has not been approved by the FDA for this particular type of cancer. It is approved for other types of cancer. This study will also use SD-101. SD-101 is an experimental drug injected by needle into your tumor. Experimental means that the drug has not been approved by the FDA. This combination treatment is experimental for chemotherapy refractory metastatic pancreatic adenocarcinoma.

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

Clinical research study of a gene therapy for patients with Parkinson's Disease (RESTORE-1)

Please consider this clinical research study evaluating the safety and efficacy of an investigational gene therapy in Parkinson's Disease

This study will test the safety and efficacy of an investigational gene therapy in people with Parkinson's Disease. The purpose is to determine if the gene therapy is better than placebo at improving PD motor symptoms. The gene therapy introduces a gene with instructions for making an enzyme that plays an important role in the production of dopamine in the brain. The therapy is injected in the brain during a surgical procedure. This study is conducted at the UC Davis Department of Neurology. Surgery and some imaging will be performed at San Francisco VA. You will receive the investigational therapy and study evaluations at no cost. Additionally, transportation, hotel stay, and parking to and from visits is available free of charge. You will also receive additional compensation for your participation in study visits.

Phase 2 study, Gene therapy
Any, age 40 Years to 75 Years (inclusive)

A Rollover Study of Experimental Avelumab for Solid Tumor Cancer

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Avelumab is a monoclonal antibody. This means it is an antibody that is active against a single specific target structure. Antibodies are usually produced naturally by the body’s immune system. They protect the body from sources of infection or agents that may be harmful to the body. Artificial antibodies, such as the study drug, can be made into medications to help prevent the growth or spread of cancer. The specific target structure that the study drug is active against may be present on the type of cancer you have. You are invited to take part in this roll-over clinical research study. It is for patients who were treated with the study drug avelumab in another clinical research study. Participants from several studies on avelumab (referred to as “parent studies”) are invited to take part.

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

A Study of Experimental Treatment with OrcaGraft for Allogeneic (donor) Transplant in Hematologic Malignancies (blood cancers)

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This research study will test if experimental OrcaGraft can be safely given to patients. It will be studied as a stem cell transplant in patients with blood cancers and pre-cancerous conditions. We are doing this research because some transplants can cause complications. One complication is called graft-versus-host-disease (GVHD). GVHD causes donor cells to attack recipient tissues. OrcaGraft is designed to minimize or eliminate potential complications and provide a safer transplant. This study will see if OrcaGraft is safe to use. We will also collect data about the best dose of cells that make up a part of OrcaGraft. This could provide data to make the composition of OrcaGraft better in the future. This study is being done at UC Davis Health and at other sites around the U.S.

Biological study, Phase 1
Any, age 18 to 65 years old

A Study to Test Dystrophin (muscle protein) Levels in Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD)

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Your child has been invited to take part in this research study because he has Duchenne Muscular Dystrophy (DMD). DMD is caused by a mutation (or error) in the gene for dystrophin. Dystrophin is a protein that keeps muscles healthy by keeping the structure of muscle cells. One type of mutation in the dystrophin gene is called nonsense mutation. This type of mutation is the cause of DMD in about 15% of boys with the disease. A nonsense mutation in the dystrophin gene causes a premature stop signal. This premature stop signal tells the body to stop making the dystrophin protein in muscle before the protein is complete. The result is a shortened dystrophin protein that does not work and weakens the muscles. The purpose of this research is to measure levels of dystrophin. It will be measured before and after nine months of treatment with an investigational drug called ataluren. This study is for children who: - are at least 2 years old and younger than eight years old. - can walk. - have Duchenne Muscular Dystrophy (DMD) caused by a nonsense mutation of the dystrophin gene.

Drug study, Phase 2
Male, age 2 to 7 years old

A Study of Experimental PET Scan for Renal Cell Carcinoma (kidney cancer)

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The current treatment for kidney cancer only benefits some patients. It can be costly and toxic. To check if treatment is working, doctors use computed tomography (CT) and/or magnetic resonance imaging (MRI). This imaging is done approximately two months after cancer treatment. In some cases where treatment is not working, those patients are unnecessarily exposed to toxic treatment. They can then switch to other potentially effective therapy. The purpose of this study is to learn a new way of imaging cancer early during the treatment course (two weeks). This will help determine if the treatment is effective. We will explore the benefit of functional PET technique for earlier prediction of cancer response.

Diagnostic Test study
Any, age 21 to 80 years old

A Study of Experimental Stem Cell Injection for Central Retinal Vein Occlusion (vision loss due to decreased blood supply in eye)

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Central retinal vein occlusion (CRVO) is an eye condition often associated with permanent loss of vision. CRVO blocks the blood supply to the retina. The retina is the part of the eye that captures the images that the eye sees and transmits the information to the brain. This blockage can damage your retina causing vision loss. In this study, we aim to learn more about a new procedure that involves injecting your own (autologous) stem cells into the eye. This approach is investigational and we do not have a lot of information about it. However, this stem cell procedure was used in a smaller study of 9 patients with different eye diseases including 1 patient with CRVO. The study was conducted by the same team led by Dr. Susanna Park at UC Davis. The aim of the current larger study is to get more information about this new procedure for patients with vision loss from CRVO. All participants will be randomly assigned to 1 of 2 groups. Both groups will receive one stem cell injection in the study eye. You will not be told which group you are in until the end of the study. Group 1 will have a bone marrow aspiration and stem cell injection during Study Period 1 or at the beginning of the study. During Study Period 2 or around 6 months into the study, Group 1 will have a sham or fake aspiration and a sham or fake injection. Group 2 will have a sham or fake aspiration and a sham or fake injection during Study Period 1 or at the beginning of the study. During Study Period 2 or around 6 months into the study, Group 2 will have bone marrow aspiration and stem cell injection.

Biological study, Phase [1, 2]
Any, age 18 years or older

A Study of Experimental Combination Treatment with Chemotherapy, Nivolumab, and / or BMS-986205 for Bladder Cancer

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This study will test the effectiveness (how well the drug works), safety, and side effects of the experimental drug called BMS-986205. It will be tested in combination with another cancer medicine called nivolumab plus chemotherapy. This study is for patients who have bladder cancer that has grown into the muscle wall of the bladder. These drugs will be compared to just chemotherapy. BMS-986205 is a small molecule and nivolumab is a human monoclonal antibody. A small molecule such as BMS-986205 is a chemical that is designed to block the function of a protein (called an enzyme) within the body. BMS-986205 is an IDO1 inhibitor. Blocking the IDO pathway may help your immune system to fight abnormal cancer cells in the body. An antibody is a type of protein that your immune system (the body's defense system against harmful particles) uses. Antibodies find and destroy foreign particles (such as bacteria and viruses). Scientists can now make antibodies in the laboratory and produce them for the treatment of many different diseases. Nivolumab is an anti-PD-1 antibody. It works by attaching to and blocking a molecule called PD-1. PD-1 is a protein that is present on different types of cells in your immune system and controls parts of your immune system by shutting it down. Antibodies that block PD-1 can prevent PD-1 from shutting down the immune system. This allows immune cells to recognize and destroy cancer cells. Nivolumab is approved to treat certain cancer types.

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