UC Davis Health Clinical Studies

Experimental TAS-102 and Irinotecan for Gastric and Gastroesophageal Adenocarcinoma (stomach cancer)

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The purpose of this research study is to test the experimental combination of TAS-102 and irinotecan. We hope to learn if it is effective in patients with gastric or gastroesophageal cancers (GEC). Both TAS-102 and irinotecan are used to treat GEC and are included in treatment guidelines. Irinotecan is not approved to treat gastroesophageal cancers. TAS-102 was approved in 2019 for patients with advanced GEC who have no other standard chemotherapy options. This is the first study to test the combination of TAS-102 and irinotecan in advanced GEC. There has been a previous study using this combination in patients with metastatic colon cancer. It was shown to have some anti-tumor effects and the dose and schedule of the combination was shown to be tolerable. We would like to see if there are similar effects in patients with advanced GEC. The purpose of this research study is to see if the combination of TAS-102 and irinotecan can slow down tumor growth in patients.

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

A Study of Experimental ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma (liver cancer)

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The purpose of this study is to find out if Study Drug ET140202 T cells are safe and if there are beneficial effects in people with liver cancer. The investigational study drug is ET140202 T cells. The word “investigational” means the study drug is still being tested in research studies and is not approved by the FDA. Your ET140202 T cell product will be made from your own T cells, a specific type of white blood cell. Your T cells will be genetically-modified in the laboratory. This means the T cells are changed by inserting additional pieces of DNA (genetic material) into the cells. This makes them recognize and kill liver cancer cells. The process of making your ET140202 T cell product is described here: • Your cells will be collected by a procedure called leukapheresis. This involves collecting your blood and separating your white blood cells from other blood components. • Your T cells, a specific type of white blood cell, will be isolated and grown in the laboratory. • Your T cells will be treated with a vector. Vectors are type of virus that can enter cells and can change the way the cell acts. • After adding the new ET140202-specific genetic material, your ET140202 T cells will be grown to larger numbers. Afterwards, the cells are washed to select the best cells and frozen. • Your ET140202 T cells will be tested to make sure they are safe for use and then administered to you.

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

A Study of Experimental CC-90001 For Non-alcoholic Steatohepatitis (NASH) and Stage 3 or 4 Liver Fibrosis

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We invite you to take part in a research study because you have been diagnosed with nonalcoholic steatohepatitis (NASH). NASH is a type of fatty liver disease in which fat builds up in your liver and over time causes inflammation (swelling) and liver cell damage. The purpose of this study is to test an experimental study drug called CC-90001. This study will test 3 doses of CC-90001 (100 mg, 200 mg and 400 mg, given by mouth, once daily). It will be compared to placebo (a “sugar pill”, an inactive substance that contains no medicine but looks exactly the same). This study is being done to test the effect of CC-90001 on your liver, and how well your body tolerates CC-90001. The study drug, CC-90001, has not been approved for the treatment of NASH and its use in this study is experimental.

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

A Study of the Safety and Effectiveness of Experimental Cilofexor for Primary Sclerosing Cholangitis (scarring of bile ducts)

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We invite you to take part in a research study because you have primary sclerosing cholangitis (PSC). PSC is a chronic disease which causes scarring of the bile ducts. When the bile ducts are damaged, the ducts become hard and narrow and this can block the flow of bile which can cause damage to the liver over time. This study will test an experimental drug named GS-9674 (also referred to as cilofexor). It will be used for the treatment of primary sclerosing cholangitis (PSC). PSC can be without symptoms, especially early in the disease. Some symptoms of PSC can include fatigue (feeling tired), itching, and jaundice (yellowing of eyes and skin). The symptoms of PSC are related to the blockage of bile flow from the scarred bile ducts and a build-up of bile acids. Patients with PSC can develop cirrhosis (severe scarring of the liver). This can lead to liver failure. PSC is also a major risk factor for the development of cancer of the bile ducts (cholangiocarcinoma). The only effective treatment for PSC is liver transplantation. This involves removing the damaged liver and replacing it with a healthy one from a donor. Experimental GS-9674 is being developed to reduce bile acids. Elevated bile acids contribute to symptoms of PSC including inflammation and fibrosis (scarring) in the liver.

Drug study, Phase 3
Any, age 18 to 70 years old

Do you have Fatty Liver or NASH? Participate in a study

We are evaluating a new investigational medicine for the treatment of NASH

We're inviting people with fatty liver or nonalcoholic steatohepatitis (NASH) to participate in a research study. The goal of this study is to see if an investigational medicine called Elafibranor is safe and effective for the treatment of NASH. Nonalcoholic steatohepatitis or NASH is a liver disease that is affecting millions of Americans. It is marked by liver inflammation and damage caused by a buildup of an unhealthy amount of fat in the liver. NASH may progress to scarring and lasting damage to the liver. Currently, no FDA approved medications are available. You will receive study medication and study evaluations at no cost, and compensation for your time is available. Experienced clinicians at the UC Davis Department of Gastroenterology and Hepatology will take care of all study participants.

Phase 3, Drug study
Any, age 18 - 75 years

A Study of Experimental Oncology Therapies Combined With Chemotherapy and Bevacizumab for Colorectal Cancer

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This is a research study of experimental medications called novel oncology therapies (durvalumab and oleclumab). They will be combined with standard treatment for your type of cancer. This study is for patients who have Metastatic Microsatellite-Stable Colorectal Cancer (MSS-CRC) and have not received prior therapy. Metastatic means your cancer has spread from your colon to another part of your body. This study has two parts: Part 1 and Part 2. The study doctor will tell you which part of the study you are being asked to take part in. The main purpose of the first portion (Part 1) of this study is to determine the safety and effectiveness of the experimental medicines. Safety will be tested by checking for: - side effects - abnormal laboratory test results, - vital signs (temperature, blood pressure, pulse rate and respiratory rate), - electrocardiogram (ECG) results. The main purpose of the second portion of this study (Part 2) is to compare the antitumor effect of the combination treatment in subjects with MSS-CRC. Researchers have found that sometimes the body’s own immune system may slow down or control cancer growth. Sometimes this natural immune system response stops, and the cancer is not killed by your own immune system. Research has shown that in some patients cancer cells and immune cells start to express signals that stop the body’s immune system from killing the cancer. New drugs such as durvalumab and oleclumab are designed to block these signals and to increase the immune response. Durvalumab is an antibody (antibodies are proteins that are produced by the body’s defense system). It targets a receptor on immune cells (receptors are proteins on the surface of a cell) called programmed cell death protein (PD-1). It is hoped that by blocking this receptor, the immune cells will once again be able to prevent or slow down cancer growth. Durvalumab has been approved by the FDA for locally advanced or metastatic urothelial carcinoma. Durvalumab has also been approved by the FDA for locally advanced non-small cell lung cancer. Durvalumab is still in the development stage for the treatment of MSS-CRC. It is not approved for treatment of MSS-CRC, except for use in research studies like this. Oleclumab (also known as MEDI9447) is also an antibody that binds to a molecule called CD73. The normal function of CD73 is to produce a molecule named adenosine. When too much adenosine is produced it can reduce the ability of the immune system to function. Oleclumab works by reducing CD73’s ability to produce adenosine. This helps the immune system to function, and potentially to prevent cancer growth. Oleclumab has not been approved by the FDA and is considered to be an “experimental drug”. FOLFOX and bevacizumab are approved anticancer medications as a treatment for your type of cancer.

Drug study, Phase [/1/,/ /2/]
Any, age 18 to 101 years old

A Study of the Effectiveness and Safety of Experimental Pamrevlumab for Locally Advanced, Unresectable Pancreatic Cancer

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You have been asked to take part in a research study designed to test an experimental drug. FibroGen, Inc. (FibroGen) is developing an experimental drug called pamrevlumab. Pamrevlumab is called “experimental” because it has not been approved by the FDA for doctors to prescribe to their patients. Pamrevlumab is a type of protein drug called a human monoclonal antibody. Monoclonal antibodies are similar to the antibodies that your body normally produces. Antibodies are made by your immune system and help you fight infections. Pamrevlumab interferes with connective tissue growth factor (CTGF). This is a protein that the body normally produces. When it produces too much CTGF, tumors may grow or spread. This study will test whether pamrevlumab is safe and effective. It will be tested in patients with locally advanced unresectable (cannot be completely removed by surgery) pancreatic cancer. It will be combined with the currently approved chemotherapy treatment (gemcitabine and nab-paclitaxel). Participants will be randomly assigned to 1 of 2 treatment groups: • Treatment Group A: Gemcitabine + Nab-paclitaxel + Pamrevlumab • Treatment Group B: Gemcitabine + Nab-paclitaxel + Placebo A placebo is a substance that looks like the study drug, but has no active study drug. You have a 50% chance of being assigned to either group.

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

Study of Experimental Eryaspase Combined With Chemotherapy for Pancreatic Cancer

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In this study the experimental drug, eryaspase, will be given with chemotherapy. The chemotherapy is already approved or used to treat patients with pancreatic cancer. The purpose of this study is to find out if giving eryaspase with the chemotherapy works better than giving the chemotherapy by itself. Patients who participate will either receive: - the experimental drug, eryaspase, plus chemotherapy or - chemotherapy only. This study is for patients who already received treatment for advanced pancreatic cancer. However, their cancer has continued to grow or has become worse. There will be 2 groups of patients, also called arms, in this study. Patients will be randomized or assigned, like the flip of a coin, to 1 of the following arms: • Arm A: Eryaspase plus standard chemotherapy (either gemcitabine + Abraxane or an irinotecan based regimen) • Arm B: Standard chemotherapy (either gemcitabine + Abraxane, or an irinotecan based regimen) You cannot choose which treatment group you will be in. Also, your doctor will not be able to choose which treatment group you are assigned. This is done using a computer system.

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

A Study of Experimental Nivolumab For Hepatocellular Carcinoma After Surgery

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This research is being done to find out if experimental durvalumab is safe for the treatment of hepatocellular carcinoma (HCC). It will be given after surgery or ablation. Durvalumab has been approved by the FDA as therapy for the treatment of other cancers. Both durvalumab and bevacizumab are still in the development stage for the treatment of HCC after curative resection or ablation. Neither are approved for treatment of HCC after curative resection or ablation, except for use in research studies like this. Researchers have found that sometimes the body’s own immune system may slow down or prevent cancer growth. Sometimes though, your immune system stops working and your body is no longer able to do this. Research has shown that cancer cells in some patients start to make signals that stop the body’s immune system from killing the cancer. One such signal is called Programmed Cell Death Ligand 1 or PD-L1 for short. New drugs like durvalumab work to stop this signal and to increase the immune response. It is hoped that by stopping this signal, the immune cells will once again be able to prevent or slow down cancer growth. Durvalumab is an antibody (a protein produced by the body’s defence system). A number of different tests will need to be done to test if durvalumab works and to learn what side effects there might be. Research has shown that some cancer cells make a protein called vascular endothelial growth factor or VEGF for short. VEGF causes the formation of blood vessels to the tumours. Research has shown that VEGF plays a role in HCC. Drugs like bevacizumab block the VEGF signal and work to stop the formation of blood vessels to the tumour

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

A Study of Experimental ABBV-323 For Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

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We invite you to take part in a research study because you have been diagnosed with ulcerative colitis. Symptoms include diarrhea with or without blood, abdominal pain, and a sudden or constant feeling that you need to move your bowels. This study is for patients who did not respond to treatment with medications that help reduce the inflammation. These medications include infliximab, adalimumab, golimumab, vedolizumab or tofacitinib. The experimental drug or “study drug” is called ABBV-323. It is being studied to treat subjects with moderately to severely active ulcerative colitis. An experimental drug is one that has not been approved by the FDA. This experimental drug or “study drug” belongs to a group of medications called a biologic. ABBV-323 is made in a laboratory and is the same as a protein found in your body called an antibody.

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