Baltimore, MD Paid Clinical Trials

This is a multi-center, open-label, first-in-human Phase 1 study evaluating the anti-programmed death receptor 1 (anti-PD-1) antibody dostarlimab (also known as TSR-042) n participants with advanced solid tumors who have limited available treatment options. The study will be conducted in 2 parts with Part 1 consisting of safety evaluation, pharmacokinetics (PK), and pharmacodynamics (PDy) of escalating doses of dostarlimab. Dose escalation will be based on ascending weight-based dose levels (DLs) of dostarlimab and will continue until the maximum tolerated dose (MTD) is reached or may be stopped at any dose level up to the highest dose of 20 milligrams per kilograms (mg/kg) based on emerging safety and PK/PDy data. Part 2 will be conducted in two subparts, Part 2A (fixed-dose safety evaluation cohorts) and Part 2B (expansion cohorts). Part 2A of the study will evaluate the safety and tolerability of dostarlimab at fixed doses of 500 mg administered every 3 weeks (Q3W) and 1000 mg administered every 6 weeks (Q6W). Part 2B of the study will examine the safety and clinical activity of dostarlimab in cohorts of participants with specific types of advanced solid tumors. Read Less

This is a Phase 2 single-blind, randomized, multicenter study to compare the efficacy and safety of a single dose of TNX-1300 to placebo with usual care in patients with acute cocaine intoxication within the emergency department setting. Read Less

To determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to abiraterone for the treatment of metastatic prostate cancer. Read Less

This study collects and stores tissue and blood samples from patients with cancer. Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help scientists create new and better models to learn about cancer and to test new cancer drugs. Read Less

This is a phase 1 study of the combination of cedazuridine with decitabine in patients with solid tumors. At least 6 patients will be enrolled per treatment level to assess optimal hypomethylation and toxicity (up to 35 patients total). Read Less

Background: Proteins are essential to the health and structure of the cells that make up body tissues. Most proteins become damaged over time and are replaced with new ones. This process is called "protein turnover." Stress, disease, and aging can affect this process. Researchers want to better understand how aging affects protein turnover. Objective: To measure rates of protein turnover in healthy adults. Eligibility: Healthy people aged 20 years and older with a body mass index between 20 and 30. Design: Participants will have 6 study visits over 4 to 6 weeks. They will fast 12 hours before each visit. Participants will be screened. They will have a physical exam, with blood and urine tests and tests of their heart function. They will lie down while blood pressure cuffs are used on their arms and legs. Participants will be given bottles of heavy water to drink at home on a schedule for 21 days. Each bottle holds about 3.5 tablespoons. Heavy water is odorless, colorless, and tasteless, like normal drinking water. It is safe to drink and has been used in research for many years. Participants will have tests during study visits, including: Imaging scans of a leg. Exercise on a treadmill. Biopsies of muscle, skin, and fat: Small samples of tissue will be cut from the calf and abdomen. Resting metabolic rate: Participants will lie still and breathe into a mask for 20 minutes. Knee/grip strength: Participants will do strength tests with their legs. They will squeeze a device with their hands. D3-Creatine: Participants will take 1 pill of D3-Creatine, which occurs naturally in muscle. Read Less

This study is designed to collect long-term safety and survival data from participants previously treated in an eligible Century-sponsored index trial. This is an observational study, and the elements of the study design allow for important follow-up for safety, survival, and the continued evaluation of any late adverse events (AEs) that may appear after treatment with such cellular products. Additionally, collection of persistence data from participants will support the identification of any long-term risks or late AEs that may be causally related to treatment with such cellular products. Read Less

The goal of this clinical trial is to compare the effectiveness of unseparated whole blood (referred to as Low-Titer Group O Whole Blood) and the separate components of whole blood (including red cells, plasma, platelets, and cryoprecipitate) in critically injured patients who require large-volume blood transfusions. Read Less

The purpose of this study is to learn the best approach to treating patients with known or suspected Barrett's esophagus by comparing endoscopic surveillance to endoscopic eradication therapy. To diagnose and manage Barrett's esophagus and low-grade dysplasia, doctors commonly use procedures called endoscopic surveillance and endoscopic eradication therapy. Endoscopic surveillance is a type of procedure where a physician will run a tube with a light and a camera on the end of it down the patients throat and remove a small piece of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells. Endoscopic eradication therapy is a kind of surgery which is performed to destroy the precancerous cells at the bottom of the esophagus, so that healthy cells can grow in their place. It involves procedures to either remove precancerous tissue or burn it. These procedures can have side effects, so it is not certain whether risking those side effects is worth the benefit people get from the treatments. While both of these procedures are widely accepted approaches to managing the condition, there is not enough research to show if one is better than the other. Barrett's esophagus and low-grade dysplasia does not always worsen to high-grade dysplasia and/or cancer. In fact, it usually does not. So, if a patient's dysplasia is not worsening, doctors would rather not put patients at risk unnecessarily. On the other hand, endoscopic eradication therapy could possibly prevent the worsening of low-grade dysplasia into high-grade dysplasia or cancer (esophageal adenocarcinoma) in some patients. Researchers believe that the results of this study will help doctors choose the safest and most effective procedure for their patients with Barrett's esophagus and low-grade dysplasia. This is a multicenter study involving several academic, community and private hospitals around the United States. Up to 530 participants will be randomized. This study will also include a prospective observational cohort study of up to 150 Barrett's esophagus and low grade dysplasia patients who decline randomization in the randomized control trial but undergo endoscopic surveillance (Cohort 1) or endoscopic eradication therapy (Cohort 2), and are willing to provide longitudinal observational data. Read Less

This is a Phase 1 dose-escalation study of PRT3789, a SMARCA2 degrader, in participants with advanced or metastatic solid tumors with loss of SMARCA4 due to truncating mutation and/or deletion. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of PRT3789 monotherapy and in combination with docetaxel, describe any dose limiting toxicities (DLTs), define the dosing schedule, and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) to be used in subsequent development of PRT3789. Read Less

The purpose of this registry is to evaluate real world experience and outcomes of patients with Upper Tract Urothelial Cancer (UTUC) treated with Jelmyto in the United States. Read Less

This study investigates how well radium-223 works in treating patients with castration-resistant prostate cancer than has spread to the bones (bone metastases). Prostate cancer is the most common cancer in men and the second leading cause of cancer death. Furthermore, many men with notably advanced disease have been found to have abnormalities in DNA repair. The purpose of this research is to study the role of a DNA repair pathway in prostate cancer, specifically in response to administration of radium-223, an FDA-approved drug known to cause DNA damage to cancerous cells. Understanding how defects in the DNA repair pathway affects radium-223 treatment of prostate, may help doctors help plan effective treatment in future patients. Read Less