UC Davis Health Clinical Studies

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

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 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)

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 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 Engineered Donor Grafts (TregGraft) for Allogeneic Transplantation for Hematologic Malignancies (blood cancer)

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 a research study of a type of blood stem cell transplant called TregGraft. TregGraft is being tested as a possible treatment of blood cancers and conditions highly likely to turn into blood cancer. TregGraft is an experimental therapy, meaning that it is not approved by the FDA. TregGraft is the study treatment in this research study. You will not receive TregGraft. Rather, it is the blood cell transplant that will be given to the recipient and will be made from your blood cells. A key part of TregGraft are healthy blood-forming cells. These will be isolated from your blood cells. When placed in the recipient’s bloodstream, they will grow and make new healthy red blood cells, white blood cells, and platelets. TregGraft also includes other specific white blood cell populations including regulatory T cells. These will also be isolated from your blood cells. When given to transplant recipients, they may prevent some of the known complications of blood cell transplants. One example is graft-versus-host disease (GVHD), a condition that involves the immune attack on recipient tissues by donor cells. TregGraft also includes “conventional” T cells, that may help fight infection or cancer, but also carry a risk of causing GVHD.

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

Study on Experimental Olaparib Plus Abiraterone for Metastatic Castration-resistant Prostate Cancer

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

This research study is for patients who have metastatic Castration-resistant Prostate Cancer (mCRPC). The reason for the study is to find a more effective treatment for this disease. The research team hopes to find out if an experimental medication called olaparib is safe and effective. It will be tested in patients who are also given abiraterone treatment. Olaparib (tradename Lynparza™) is approved by the FDA for other types of cancer. It is considered experimental in this study. Abiraterone is already an approved medication for the treatment of some patients with prostate cancer.

Drug study, Phase 3
Male, age 18 to 99 years old

A Study of Experimental AB-205 in Adults With Lymphoma Undergoing Autologous (from self) Stem Cell Transplantation

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

You are invited to be in this study because you have lymphoma. A clinical trial is a type of research study. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer. Clinical trials include only people who choose to take part. This is a first in-human study. The purpose of this research is to find out if the experimental product, AB-205, is safe. AB-205 is made up of engineered (modified) human endothelial cells. The endothelial cells are cells that line the inside of blood vessels including the umbilical cord. AB-205 is made from human umbilical endothelial cells that are collected from the umbilical cord of a healthy newborn baby. This research study will test the safety of a single dose infusion of AB-205, given after a bone marrow transplant. The study goal is to test the highest dose of AB-205 to be given in humans with Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL). Patients are in a chemo-sensitive remission undergoing high-dose therapy (HDT), with or without radiation. Participants have an autologous stem cell transplant. This is a type of transplant in which a person’s own stem cells are taken, preserved and returned to them.

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

A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors

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 study is to test the safety and effectiveness of an experimental cancer treatment called NeoTCR-P1. This is a research study for people who have been diagnosed with cancer. Specifically: - advanced melanoma, - bladder cancer, - colorectal cancer, - ovarian cancer, - breast cancer, or - prostate cancer The study is for patients whose cancer has gotten worse after standard therapy and no additional therapies are available. This research study will take some of your own white blood cells, modify them in a laboratory, and re-infuse them back into you. White blood cells are part of the body’s immune system. They help the body fight infection and other immune diseases. Types of white blood cells are granulocytes (neutrophils, eosinophils, and basophils), monocytes, and lymphocytes (T-cells and B-cells). In this study, your T-cells will be modified so that they can identify and possibly kill your cancer cells. Cancer cells have markers, called “neoantigens”, on their surface that are unique and specific to each person’s tumor. You can think of neoantigens as a tumor’s hidden fingerprint. Your T-cells will be modified to recognize your tumor’s specific neoantigen. The modification is a genetic change, or gene transfer, to your normal T-cells. This means that a section of DNA (genetic material) in your T-cells will be replaced. A specific DNA sequence will be put in its place to help your T-cells identify and locate your tumor cells. A receptor is a protein molecule on a cell’s surface. It receives chemical signals from outside the cell and translates them into a response inside the cell. This modification will add a new receptor to your T-cells so that they recognize cancer cells expressing neoantigens specific to your tumor. This type of genetic modification has not been tested in humans. These modified T-cells are called “NeoTCR-P1” T-cells. NeoTCR-P1 will be given back to you through your vein in one infusion. Unlike standard drugs that are broken down by your body, NeoTCR-P1 is a “living drug.” It is able to proliferate (expand the number and type of stimulated T-cells) extensively in participants. The actual number of cells that expand after infusion will vary from participant to participant. The use of NeoTCR-P1 is experimental and has not been approved by the Food and Drug Administration (FDA) for use outside this study. NeoTCR-P1 is being tested in humans for the first time under this study. Providing your blood for the collection of genetic material to be used in the production of the study drug is not optional in this study.

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

A Study of Experimental Elacestrant vs. Standard of Care for ER+/HER2- Advanced Breast Cancer

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 research study because you have advanced breast cancer that is either: - estrogen receptor positive (ER+) or - human epidermal growth factor negative (HER2-) Researchers want to find out if an experimental drug called elacestrant, can help people with your type of advanced breast cancer. Elacestrant is also known as RAD1901. It is an experimental drug that impacts the estrogen receptor. It is under investigation for the treatment of ER+, HER2- advanced breast cancer. An “experimental drug” is a drug that is being tested and is not approved for sale by the FDA. Researchers want to test elacestrant in subjects with advanced breast cancer. They hope to learn: - if it can prolong time to worsening (progression) of the breast cancer, - how it affects cancer cells and - about any unwanted health effects, also called “side effects”, it may cause.

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

A Study of Experimental NGM120 Combination Therapy for Advanced Solid Tumors and Pancreatic Cancer

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

NGM120 is an experimental drug made by NGM Biopharmaceuticals, Inc. (the “Sponsor” of this clinical trial). The term “experimental” means that the drug has not been approved by the U.S. Food and Drug Administration (FDA). NGM120, given as an injection, is designed to block a factor that is associated with cancer. NGM120 has shown in various animal models of cancer to reduce tumor size and improve symptoms of cancer. The purpose of this study is to find out the effects of the study drug “NGM120.” We wil also test the combination of NGM120 and standard therapy (gemcitabine and Abraxane). We want to know the effect it may have on you and your type of cancer and your cancer associated loss of appetite, weight loss and loss of muscle.

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

A Study of Experimental Tucatinib vs. Placebo Combined With Ado-trastuzumab Emtansine (T-DM1) for HER2+ Breast Cancer

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

We’re asking you to take part in a clinical trial (study) because you have HER2 positive breast cancer that has started to spread or has already spread through your body. “HER2 positive” means that your cancer cells make a protein called HER2. This clinical trial uses an experimental drug. This means the Food and Drug Administration (FDA) hasn’t approved it for sale in the United States. This drug is called tucatinib. This trial also uses another drug called ado-trastuzumab emtansine (T-DM1). The brand name for T-DM1 is KADCYLA®. T-DM1 has already been approved by the FDA for treatment of your type of breast cancer. Your doctor might choose to talk with you about this treatment even if you’re not in this clinical trial. We are studying tucatinib plus T-DM1 to find out what the side effects are and if it works for treating HER2 positive breast cancer. A side effect is anything the drug does to your body besides treating your disease. We don’t yet know if tucatinib plus T-DM1 is better or worse than other treatments. Learning about the side effects of tucatinib plus T-DM1 and how it works will help us understand if tucatinib plus T-DM1 is better or worse than other treatments. We want to find out how effective tucatinib plus T-DM1 is compared to treatment with only T-DM1. To do this, we will compare 2 groups in this study. One group will get tucatinib plus T-DM1 and the other group will get a placebo plus TDM1. A placebo is a pill that doesn’t have any drug or medicine in it. We will choose your group randomly, like tossing a coin. This means that you might get tucatinib plus T-DM1 or you might get placebo plus T-DM1. We won’t know which group you’re in until the end of the clinical trial. Your doctor and the study staff won’t know which group you’re in either. Clinical trials include only people who choose to be in them. Please take as much time as you need to make this choice. You can talk with your friends and family about your options. You can also talk with other doctors and nurses you know. If you have any questions, ask your study doctor before making your choice. This form tells you about the risks and possible benefits of this clinical trial. It explains what will happen if you take part. Your study doctor will also explain the clinical trial to you. After you read this document and have your questions answered, we will ask you to decide if you want to be part of this clinical trial. This process is called informed consent. You have other options to consider for your breast cancer. Discuss these options with your doctor so that you know the risks and benefits of all your choices before you decide. When you understand the study, including the risks and benefits, you must sign this form if you want to take part in the study. We will give you a copy of the signed form to keep

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