An Open-Label Multi-Center Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes
This is an open label, multi-center, retrospective and prospective clinical study. Patients who are to undergo shoulder arthroplasty may be screened for participation. Likewise, patients who have previously undergone shoulder arthroplasty with the Equinoxe®, or other arthroplasty systems, may be screened for enrollment. This study may include patients from multiple centers, both US and international, undergoing hemi- or total shoulder joint replacement. Patients will be screened for enrollment based upon the inclusion and exclusion criteria described in the protocol.
AN OPEN-LABEL MULTICENTER PHASE 1/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF AB-2100 IN PATIENTS WITH RECURRENT ADVANCED OR METASTATIC CLEAR-CELL RENAL CELL CARCINOMA (CCRCC)
This is a study seeing if a new cellular medicine called AB-2100, a logic-gated CAR T cell targeting PSMA and Ca-IX, is effective for adult patients with a specific type of advanced kidney cancer called clear-cell renal cell carcinoma (ccRCC). The study team wants to the safety and anti-cancer effectiveness of this medicine. Patients will try different doses of AB-2100 in the first part of the study, and once they figure out the right amount that has tolerable side effects, more patients will receive the treatment in the second part. The study is split into different steps for each patient, like checking if they're a good fit for the study, getting cell samples from the patient, preparing the body for treatment, receiving the medicine, and then seeing how things go afterward concerning treatment.
AN OPEN-LABEL MULTICENTER STUDY OF LOXO-435 (LY3866288) IN ADVANCED SOLID TUMOR MALIGNANCIES WITH FGFR3 ALTERATIONS
This is a study of a drug called LOXO-435 for patients with advanced solid tumors, specifically focusing on metastatic urothelial cancer (mUC) that has a change in a gene called FGFR3. The study will be conducted in two phases. Phase 1a is the first part and will test different doses of LOXO-435 to determine its safety, how well it is accepted by the patient's body, how the body processes it (pharmacokinetics), and its initial effectiveness. This phase will include patients with any type of solid tumor that has an alteration in the FGFR3 gene or its related proteins. The goal is to find the recommended dose for the next phase. Phase 1b is the second part and will involve four groups of patients receiving the recommended dose from Phase 1a. These groups will include patients with urothelial cancer, either as a single treatment or in combination with pembrolizumab (another drug), as well as patients with other types of advanced solid tumors who will receive LOXO-435 alone. The purpose is to evaluate the effectiveness and safety of LOXO-435 in these specific patient groups.
An Open-label Phase 1 Multicenter Study to Evaluate the Safety and Preliminary Anti-tumor activity of NT-112 in Human Leukocyte Antigen-C*08:02-Positive Adult Subjects with Unresectable Advanced and/or Metastatic Solid Tumors That Are Positive for the KRAS G12D Mutation
This study is testing a NT-112, a type of cellular therapy, in patients with advanced cancer, such as lung, pancreatic, or colorectal cancer, who have a specific genetic change called KRAS G12D. The study team wants to see if the medicine has few side effects and is effective in treating the cancer. They will try different amounts of the medicine to find thehighest dose that patients can handle without severe side effects. The researchers will carefully follow a plan to decide how much medicine each patient will get. The study team will keep a close eye on any side effects. The study has different periods, like screening, where they check if people meet the criteria, enrollment, treatment, and follow-up. Patients will go through various tests before joining the study, and the researchers will collect information about safety, effectiveness, and other factors.
An open-label phase I dose escalation expansion study of MGY825 in adult patients with advanced non-small cell lung cancer
This study wants to figure out if a new medicine called MGY825 is safe and helpful for patients with advanced non-small cell lung cancer. They also want to learn how the body handles this medicine and if it can shrink tumors. The main aim is to make sure it's safe and useful for future treatments. They'll watch closely for any side effects, adjust the doses as needed, and see how it affects the patients overall. The study has two parts: first, they'll find the safest and most effective dose, and then they'll test it on different groups of patients. They're especially interested in patients with specific genetic changes (NFE2L2/KEAP1/CUL3) and certain enzyme levels because these things might affect how well the medicine works. The ultimate goal is to offer better treatments for those with advanced lung cancer who have already tried other options.
An Open-label Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination with Pembrolizumab Versus Treatment of Physician s Choice in Participants with HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer
This clinical study will evaluate MK-2870 either alone or in combination with pembrolizumab versus TPC in participants with HR+/HER2- (both HER2-zero and HER2-low) unresectable locally advanced or MBC, who have not been previously treatedwith chemotherapy in the metastatic setting.
An open-label randomized trial of zanidatamab with standard-of-care therapy against standard-of-care therapy alone for advanced HER2-positive biliary tract cancer (BTC)
This study is testing a new treatment called zanidatamab to see how well it works and how safe it is for people with a type of cancer called HER2-positive biliary tract cancer (BTC), which affects the gallbladder and bile ducts and cannot be removed by surgery or has spread to other parts of the body. Participants may receive up to two cycles of chemotherapy (cisplatin and gemcitabine, or “CisGem”) before being randomly assigned to one of two groups. In Group A, participants will get zanidatamab plus CisGem, with or without an immune therapy drug (like durvalumab or pembrolizumab). In Group B, participants will get CisGem, with or without the immune therapy drug. The treatment will continue until the cancer gets worse.
An Open-label Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of EDG-7500 in Adults with Hypertrophic Cardiomyopathy
The purpose of this study is to learn about the safety and tolerability of an investigational study drug called EDG-7500 for the treatment of hypertrophic cardiomyopathy (HCM). The study will also measure levels of study drug and any possible metabolites (break-down products of the study drug) and biological markers (biomarkers) in the blood. Biomarkers are substances in your blood that help us understand how the body is reacting to the study drug.
AN OPEN-LABEL TREATMENT WITH RANDOMIZATION OBSERVATION INVESTIGATOR-INITIATED STUDY ON THE DURATION AND EFFICACY OF JORNAY PM (METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES) ON ADULT ADHD SYMPTOMS AND EXECUTIVE FUNCTION AND EMOTIONAL REGULATION THROUGHOUT THE DAY INTO EARLY EVENING
The purpose of this research study is to examine the efficacy of Jornay PM on Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms and Executive Function throughout the day into early evening. This study will last approximately 11 weeks with will involve about 11 visits that are conducted both remote (WebEx/Telephone) and in the clinic.
Andrew W. Brotman, MD | NYU Langone Health
Dr. Andrew W. Brotman is NYU Langone’s executive vice president and vice dean for clinical affairs and strategy, chief clinical officer.