The purpose of this Study is to find out if dabogratinib, also known as TYRA-300 (which is also known as "Study Drug") is safe and effective at treating low grade upper tract urothelial cancer. Some patients have a certain alteration, or mutation, in the FGFR3 gene (a protein in the body) that can lead to cancer. The Study Drug is an experimental treatment (not approved by the United States Food and Drug Administration [FDA] or any other regulatory agencies) that blocks the abnormal activity of FGFR3 in cancer cells which might be "driving" this type of cancer.
Most patients with this type of cancer have the FGFR3 alteration in their tumor(s) but there are some patients who do not. Participants that join this study could be on it for a few months up to 24 months.
The purpose of this research is to test the safety, tolerability and effects of the investigational drug JANX014 in adults with metastatic castration-resistant prostate cancer. The study will also look at how the body processes JANX014, how the immune system responds, and whether the drug shows signs of effectiveness against prostate cancer. JANX014 is an investigational drug created by Janux Therapeutics, Inc. This study is to be conducted in 2 parts. Which part someone is assigned to will be determined by the study progress, and when the subject is eligible to participate. Dose Escalation (Part 1), participants will receive increasing doses of JANX014 by intravenous (IV) infusion to find the safest and most effective dose. Expansion (Part 2), once safe doses are identified, more participants will receive JANX014 to further evaluate safety and early signs of benefit.
We are testing a new investigational drug that may help patients with cancer gain and/or maintain their weight. "Investigational" means the "treatment has not been approved for sale by the United States Food and Drug Administration (FDA). The purpose of this study is to evaluate safety and the effects of different doses of an investigational drug called B07 on a patient's weight to see if their weight can be maintained, or increased slightly while they are receiving chemotherapy for their advanced colorectal cancer. In addition to their weight, the study will also look at the effects of B07 on their BMI (a measure of weight divided by height that is useful for determining who is underweight, normal, overweight, or obese), appetite, food intake, physical and psychological well-being, and quality of life as they undergo your cancer treatment.
This study is recruiting patients receiving cancer treatment that includes a type of drug called an "alkylating agent", which may cause side effects such as damage to the ovaries (female reproductive organs). The goal of the study is to determine the feasibility of conducting a cross network, multi-site, randomized clinical trial of triptorelin among newly diagnosed adolescent and young adult (AYA) female cancer patients age <40 years (exclusive of breast cancer). The triptorelin used in this study may affect how different parts of your body work such as your liver, kidneys, heart, and blood. Participants will receive the medications through an intramuscular (IM) injection in their arm. Study participation is expected to last up to three years.
This study is for adults diagnosed with advanced melanoma (a kind of skin cancer) that has spread or cannot be surgically removed. This study includes participants with advanced melanoma from any part of the body except the eye.
The main purpose of this research study is to learn if the study drug, brenetafusp (IMC-F106C), in combination with a standard therapy (nivolumab), works better than the standard therapy (nivolumab alone or in combination with relatlimab) at making tumors stop growing (or shrink). Nivolumab and relatlimab are FDA approved, however, the study drug, brenetafusp, is still being investigated and is not approved by the FDA.
Patients may participate in this study for up to 2 years. Procedures include CT, MRI, blood tests, drug administration, and regular visits with your doctor including follow-up study visits or phone calls. There will be about 680 people taking part in this study, approximately 5 patients will be enrolled at MUSC.
Risks include cytokine release syndrome, which could include flu-like symptoms such as nausea, vomiting, fever, tiredness, headache, chills, difficulty breathing and/or low blood pressure (symptoms may include dizziness or light headedness). Participants may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.
This study is being offered for patients with metastatic pancreatic adenocarcinoma who have tried available approved treatments and do not have satisfactory treatment options or are unable to participate in a clinical trial. The purpose of this Expanded Access Program (EAP) is to provide access to daraxonrasib, an investigational drug that has not yet been approved by the FDA.
Daraxonrasib is an oral tablet. Clinic visit are every 28 days to receive a new supply of daraxonrasib. Participation is expected to last until whichever of the following occurs first - 1: you are no longer benefiting from daraxonrasib; 2: daraxonrasib becomes commercially available (FDA approved); 3: Revolution Medicines, the Sponsor of the EAP, the IRB, or the FDA decides to stop the EAP.
Risks include skin rash, diarrhea, nausea and vomiting, mouth sores, and swelling. This EAP is not a research study. Its main goal is to provide access to daraxonrasib to patients who may benefit based on what information is known about the drug so far. There is no guarantee that your cancer will get better as a result of receiving daraxonrasib. It is possible that you will show no improvement or that your cancer could get worse.
This study is for patients that have been diagnosed with advanced solid tumors. This study is testing an investigational drug called At0365-P1-01. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to evaluate how safe the drug is, how well participants can handle the drug, how it moves through the body, how it affects the body, and if the drug helps treat the cancer of AT03-65. AT03-65 is administered via intravenous (IV) infusion. Participants can continue to receive this study drug until it no longer gives them benefit. The estimated study duration is approximately 30-35 months for subjects screening, treatment and follow-up.
This study will enroll patients with different types of cancer, as well as healthy patients with no history of cancer, into four cohorts to collect urine and/or blood samples only. The study will collect biospecimen samples to support further development of a urine-based ctDNA test. The study will enroll a total of 920 patients over 4 years.
This is a treatment plan to provide recombinant Bacillus Calmette-Guérin (rBCG) to patients with bladder cancer who are eligible to receive TICE® BCG and may benefit from its use. The treatment plan will end if the product is approved for use in the United States or if a Food and Drug Administration (FDA) clinical trial proves rBCG treatment to be ineffective. The drug is not currently FDA approved for bladder cancer.
Subjects will receive rBCG. They will have tests, exams and procedures that are part of standard of care (SoC) and for treatment plan purposes. Participants will receive treatment based on TICEBCG protocol at their local institutions.
This study is for patients that have been diagnosed with platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. The study is testing and investigational drug called INCB123667. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to evaluate the efficacy and safety of INCB123667 in terms of objective response rate (ORR) as assessed by an independent review committee (IRC). The drug is given to participants orally. Participants can expect to be on this study for approximately 24 months.