The purpose of this study is to evaluate investigational treatments (study drug) for unresectable metastatic colorectal cancer to determine if any of these study treatments improve overall survival as compared to standard treatments. The goal is to determine the optimal dose level, safety, and tolerability for the study drug ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab. The study consists of two stages, Stage 1 - Safety Lead-In Dose Escalation and Stage 2- Dose Optimization. ABBV-400 is not FDA approved. Bevacizumab is FDA approved by the U.S. Food and Drug Administration (FDA) to treat various cancers but may not be approved for your type of cancer. Treatment for this study may be up to 3 years. The procedures include blood and urine samples, questionnaires, infusions, and CT scans. Risks include diarrhea, nausea, vomiting, fatigue, and numbness, tingling, or weakness in arms and legs. You 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.
The purpose of this study is to test whether a drug called efzofitimod (the study drug) is a potential treatment for patients with Systemic Sclerosis associated with Interstitial Lung Disease (SSc-ILD).
Efzofitimod is an investigational drug that is given by infusion every 4 weeks for a total of 6 doses. An investigational drug is not approved by The US Food and Drug Administration. It can only be used in a research study like this one. In this study, efzofitimod will be compared with a placebo (dummy drug). The placebo will be a saline solution that does not have any study drug in it. The comparison with the placebo helps to determine whether the effects seen in your body is because of efzofitimod or not. This is a randomized study, meaning that you will be assigned by chance (like flipping a coin) to receive either the study drug or placebo. The study is double-blinded study, meaning you and your study doctor will not know what you are receiving, the study efzofitimod or placebo.
The study is sponsored by aTyr Pharma, Inc. Participation in the study will require 9 visits to the MUSC main campus and will have the following procedures completed over the course of your participation: blood draw, urine collection, physician-led assessments of your disease (for example physical exam and skin thickness testing), tests to assess your pulmonary function and health (Pulmonary Function Test (PFT) and High Resolution Computed Tomography (HRCT)), electrocardiogram, as well as asked to complete surveys.
Compensation is available for participation
HIV infected cocaine users have uncontrolled viral levels and impaired immunity to control infection compared to HIV infected non-drug users. We ask the questions why cocaine use makes HIV infected cocaine users more sick than other patients. The goal is to improve immunity to control HIV infection in cocaine users. Both uninfected cocaine users and HIV-infected cocaine users are especially needed in this study.
The study is for patients that have been diagnosed with carcinoma in situ of the bladder (localized bladder cancer, also called "non-muscle invasive bladder cancer") with or without Ta-T1 papillary disease (Ta means that the cancer is only in the innermost layer of the bladder lining, T1 means that the cancer has started to grow into the connective tissue beneath the bladder lining). The investigational drug used in this study is ONCOFID-P-B. The main purpose of this study is to understand if the study medicine ONCOFID-P-B is effective and safe in treating patients with carcinoma in situ of the bladder who have not received benefit from the standard BCG treatment and are not candidates for radical cystectomy. Participants can expect to be in this study for up to 4 years and will include a screening period of up to 4 weeks followed by up to 33 study visits to the study site.
The purpose of this study is to assess the feasibility and safety of modified surgical eyeglasses to view bevonescein intraoperatively and the safety of bevonescein as it shows nerve tissue in the body. Bevonescein is an investigational drug being developed to help doctors identify nerves within the body during surgery.
The drug is administered through a vein in the arm and into the blood stream.t Bevonescein then travels through the blood where it makes nerve tissue fluorescent so that it can then be detected by the modified surgical eyeglasses used in this study by a surgeon. This may help the surgeon (study doctor) to tell the difference between nerve tissue and other tissue during surgery. Bevonescein and the modified surgical eyeglasses that your surgeon will wear (ReVealTM 475) are considered investigational because they are not approved by the Food and Drug Administration (FDA) to help with the visualization of nerves during surgery Alternatives to this study can include to undergo surgery without the study drug.
The duration of this study is about 2 months. The procedures of this study include administration of the study drug once (500 mg), collection of blood and urine samples, and ECGs. Surgery will happened as planned by the study doctor but as part of the research, the surgeon will ear modified surgical eyeglasses to view nerves and may take pictures or video clips. The glasses are FDA cleared but the modified filter and its use in combination with bevonescein is considered experimental.
The most commonly expected risks of fluorescein are nausea, vomiting, and stomach discomfort. Because bevonescein is cleared through the urine, there may be a potential risk to the kidneys and renal (kidney) system. The most serious risks of fluorescein may include severe local tissue damage, anaphylaxis, convulsions, cardiac arrest, and death.
This will be a 26-week, prospective, multicenter, randomized, double-blind, placebo-controlled safety and efficacy study of udenafil 87.5 mg tablets versus placebo (both taken twice daily in adolescent subjects who have had the Fontan procedure. The primary efficacy endpoint will be change from baseline at 26 weeks in peak minute oxygen consumption [VO2] (mL/kg/min).
The study is for patients who have been diagnosed with non-squamous non-small cell lung cancer (NSCLC). The investigational drug in this study is ivonescimab (AK112). The study drug is an antibody, it blocks two proteins in the body that help cancer cells live, grow and spread. The study drug will be given in addition to pemetrexed and carboplatin. There are two groups that a participant may be assigned to, which group a subject is assigned on will be determined by type of cancer treatments that they have previously received. Treatment Group A will receive the study drug along with pemetrexed and carboplatin. Treatment Group B will receive placebo along with pemetrexed and carboplatin. The drugs will be given via an infusion. There is a 50% chance of being assigned to either group. Participation in the study will last about 36 months. The study consist of a screening visit, treatment visits, and a safety follow up visit.
The purpose of this research is to determine the safety and tolerability, the best dose for future development, as well as antitumor activity of a new antibody drug conjugate (ADC) called MYTX-011. MYTX-011 is a new drug, being studied in humans for the first time for treatment of advanced non-small cell lung cancer. The study team is investigating this drug to help treat lung cancers that are resistant to standard medications. This drug targets a protein called cMET on the cancer cell. MYTX-011 will attach to the cMET and release chemotherapy into the cancer cell.
This research is being done to better understand how anti-cancer drugs affect cells within a tumor. Injecting very small amounts (microdoses) of pembrolizumab alone or in combination with MK-0482 or MK-4830 above may help the developer of these drugs to understand more about how these drugs work and what changes they make on the tumor. Subjects in this study will have their tumor injected with anti-cancer drugs using a CIVO device. The CIVO device delivers microdoses of multiple drugs or drug combinations directly into the tumor. Some of the procedures in this study include ultrasound assisted placement for tumor injection, a mucrodose injection of anti-cancer drugs into the tumor, and surgery to remove the tumor. Participation in the study will take 5 visits over a period if 56 days. The screening portion will be 28 days and the treatment portion will be 28 days from the time of the injection to the time of follow-up contact by the study team.
This is a study comparing the new class anticoagulants factor XIa to the FDA approved Apixaban. The study is to determine if Milvexian is as effective and safe with preventing clots for patients with A-fib and to determine if Milvexian is better at reducing the chances of bleeding.