This study is for patients who have cancer and are experiencing loss of weight and appetite. The study wants to find out if this taking olanzapine for four weeks will increase your appetite as compared to megestrol acetate. The study is looking to see if that approach is better or worse than the usual approach for your loss of appetite and weight. The usual approach is defined as care most people get for loss of appetite.
This research study is enrolling participants that have been diagnosed with advanced gastric cancer (a disease in which cancer cells form in the lining of the stomach) or gastroesophageal junction cancer (a type of cancer forming in the area where the tube that connects the mouth and the stomach join together) and have not received prior treatment for advanced cancer and the tumor has already tested positive for fibroblast growth factor receptor 2b (FGFR2b) expression. FGFR2b is a protein that possibly causes cells to grow more quickly and multiply abnormally. The purpose of this study is to see if bemarituzumab is safe, tolerable, and effective when administered along with mFOLFOX6 (a combination of 5 fluorouracil [5 FU], oxaliplatin and leucovorin) and nivolumab and whether it causes any side effects. Bemarituzumab is not approved by the Food and Drug Administration (FDA). Participants will be pre-screening to see if they qualify to participate in Part 2. During the pre-screening portion, participants will provide either archived tissue or a fresh tumor sample in order to test for FGFR2b proteins. If the test results show an excessive amount of FGFR2b proteins in the tumor, participants may be asked to consider participating in the Part 2 study involving bemarituzumab, an investigational drug for people with advanced gastric or gastroesophageal junction cancer. Participants in this study will receive either bemarituzumab with mFOLFOX6 and nivolumab or placebo with mFOLFOX6 and nivolumab. The placebo will look like bemarituzumab but it will not contain active ingredients and has no effect on participants' condition. This study involves pharmacokinetic testing which is a blood test to determine how much study drug is in the blood. Bemarituzumab is not approved by the Food and Drug Administration (FDA). Participants could be in this study for up to 40 months and up to 57 visits.
This study is for patients with invasive cancer I-IV and be scheduled to receive anti-PD-1/-L1 ICI-containing therapy. This study is being done to see if we can understand which patients will develop side effects from immune checkpoint inhibitors, and what kind of side effects they will get and can we predict long-term treatment outcomes after immune checkpoint inhibitor treatment, like which patients will have a cancer that shrinks or disappears.
An experimental drug called HCW9218 is being tested in this study. HCW9218 is not approved by the Food and Drug Administration (FDA) or any other health authority for the treatment of cancer or any other disease. Since HCW9218 is experimental, it is only available to people taking part in this study. This study is for participants diagnosed with advanced pancreatic and the disease has spread or cannot be surgically corrected. This is a Phase 1b/2 study, meaning that it is a first in human research study and there is no data on HCW9218 in humans. This study tests different doses of HCW9218 to see which dose is safer in people, how well the treatment is tolerated and whether it has effects on the disease. The study doctor will tell participants which part of this study that they will take part in, the dose escalation phase or dose expansion phase. The dose escalation phase the part of a study that determines the best dose of a new drug or treatment. In a dose-escalation study, the dose of the test drug is increased a little at a time in different groups of people until the highest dose that does not cause harmful side effects is found. In the dose-expansion part of a study allows more participants to receive the study drug to further test the potential side effects of the drug. HCW9218 is given as an injection under the skin (subcutaneous injection). If participants continue in this study, he/she will begin receiving HCW9218 treatment every 28 days. HCW9218 is given as an injection under the skin (subcutaneous injection). For each day participants receive HCW9218, participants will be treated as an outpatient in a treatment center. Participants will be asked to stay in the treatment center for up to 6 hours after the first dose, 3 hours after the second dose, and 30 minutes after subsequent doses, so that the study team can carefully monitor the body's functions and closely watch for potential side effects of the study drug. This study will last about 4 years. Participants will be treated with HCW9218 until disease progression or until they can no longer tolerate the study drug. Participants could be in this study for up to 3 years. There may be risks associated with being treated with HCW9218. Some of the most common side effects that the study doctors know about based on drugs that are similar to HCW9218 are: injection site irritation/ reaction, fatigue/ tiredness, and flu-like symptoms.