A Phase 2 Double-blind Placebo-Controlled Study to Evaluate LY3537021 for the Treatment of Chemotherapy-Induced Nausea and Vomiting in Adult Participants With Malignant Disease
This is a Phase 2 study testing how safe and effective a medicine called LY3537021 is when added to standard anti-nausea treatment. LY3537021 is a long-acting drug made in a lab that works on the GIP receptor. The standard treatment includes three medicines: a 5-HT3 blocker, an NK1 blocker, and dexamethasone. The study team will compare this combination with the standard three-drug treatment alone to see which works better at controlling chemotherapy-related nausea and vomiting. The study will include patients who have never had chemotherapy and are scheduled to get either AC chemotherapy or cisplatin at a high dose. The study is randomized and double-blind, meaning neither patients nor doctors know who gets the drug or placebo (fake pill). Eligible patients will be randomly assigned to get either LY3537021 or a placebo, along with the standard anti-nausea treatment (three medicines), on the first day of each chemotherapy cycle. Patients can only get the drug after the doctor confirms they are ready for chemotherapy. Patients will receive the study treatment for 2 cycles of chemotherapy. After the last cycle, or if a patient stops early, there will be a follow-up visit to make sure the treatment is safe. A safety committee will look at unblinded safety data early in the study and provide periodic safety reviews as needed. The results will help choose the best dose for future studies.
A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)
This study is designed to compare the antitumor activity of V940 in combination with BCG to BCG monotherapy, and evaluate safety of both treatments, in participants who have high risk NMIBC and are BCG-naïve (Cohort A), and, in an exploratory fashion, eva
A Phase 2 Open-label Study Evaluating Dosimetry Randomized Dose Optimization Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants with PSMA PET-Positive Castration-Resistant Prostate Cancer
This is a three-part study which includes biodistribution (Part 1), dose optimization (Part 2) to determine the optimal dose of Ac-225 rosopatamab tetraxetan to be evaluated in future studies, and dose escalation (Part 3) in post-Lu-177-PSMA-RL participants using the Bayesian optimal interval (BOIN) design. The study will evaluate participants with CRPC previously treated with at least one ARSI with and without prior exposure to Lu-177-PSMA-RL.
A Phase 2 Open-label Study of the Effect of Adjunctively administered ABX-002 on Brain Bioenergetics in Adults with Bipolar Disorder Experiencing an Episode of Depression
The main purpose of this study is to learn how ABX-002 affects brain processing and symptoms of depression by using brain imaging called techniques called Magnetic Resonance Spectroscopy (MRS) and functional Magnetic Resonance Imaging (fMRI). NYU Langone Health is recruiting healthy volunteers to participate. Participants in this group will not be given the study drug.
A Phase 2 Open-Label Study to Evaluate the Safety and Efficacy of DCR-PHXC in Patients With Primary Hyperoxaluria Type 1 or 2 and Severe Renal Impairment With or Without Dialysis PHYOX7
The aim of this study is to evaluate DCR-PHXC in participants with PH1 or PH2 and severe renal impairment, with or without hemodialysis or peritoneal dialysis.Primary hyperoxaluria is typically diagnosed by measuring oxalate levels in urine. However, as kidney function decreases, the renal excretion of oxalate also decreases and may no longer reflect daily oxalate loads (Perinpam et al., 2017). Decreasing renal excretion of oxalate results in increasing Pox levels (Hoppe et al., 1998, Hoppe et al., 2009). Because a decrease in Pox is reasonably likely to predict clinical benefit due to its causal role in systemic oxalosis in CKD Stages 3b to 5, Pox may be a more relevant endpoint in patients with PH who have severe renal impairment (Milliner et al., 2020).
A Phase 2 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy Safety Tolerability and Pharmacodynamics of Intrathecally Administered ALN-APP in Patients with Cerebral Amyloid Angiopathy (CAA)
The purpose of this study is to test the safety and efficacy of Mivelsiran (ALN-APP) and find out what effects, if any, Mivelsiran (ALN-APP) has on people with Cerebral Amyloid Angiopathy (CAA).
A Phase 2 randomized open-label active-controlled study of JNJ-90301900 in combination with chemoradiation followed by durvalumab in locally advanced and unresectable Stage III non-small cell lung cancer
This is a Phase 2 study testing whether adding a new medicine, JNJ-90301900 (radioenhancer) to the standard treatment of chemotherapy and radiation, followed by a medication called durvalumab (a type of immunotherapy) can be a better treatment option for patients with a type of lung cancer called non-small cell lung cancer (NSCLC). This study will be done in two parts. In Part 1, patients will be enrolled sequentially into two groups to receive a JNJ-90301900 injection at two different dose levels along with standard treatment of chemotherapy and radiation, followed by a medication called durvalumab. In part 2, the patients will be randomly divided into three groups. Patients in Groups A and B will receive the study medicine at two different dose levels along with standard treatment of chemotherapy and radiation, followed by a medication called durvalumab. Patients in Group C will receive the standard chemotherapy and radiation treatment, followed by a medication called durvalumab. The study will compare the effects of this new combination treatment with those of the standard treatment alone. All patients will have blood samples taken to see how their bodies handle the study medicines and how well the cancer responds to this treatment over time. Patients will have special scans taken to monitor how the cancer is changing in response to the study medication. The study team will monitor all patients for side effects and safety concerns throughout the study. All patients will be followed up after their last study dose for up to 24 months.
A Phase 2 Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 1)
This is a phase 2 study to test whether the new study medicine, INCB123667 (CDK2 inhibitor), is safe and effective in patients with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer whose tumors express the protein called cyclin E1. Patients will be divided into three groups based on Cyclin E expression levels. All patients will receive the study medicine INCB123667, oral medication, at a dose of 50 mg on each day of a 28-day cycle. The study team will collect blood samples from all patients to check how their bodies respond to the study medication. A special blood test will be conducted to monitor changes in tumor DNA released into the blood (ctDNA) over the course of treatment. CT scans will be done for all patients to see how the tumor size is changing in response to the study treatment. The study team will examine how effective the medicine is, and how long it takes for the cancer to come back in patients who receive the study medicine. All patients will be closely watched for potential side effects and safety concerns.
A Phase 2 Study of Blinatumomab in Combination with Chemotherapy for Infants with Newly Diagnosed Acute Lymphoblastic Leukemia with Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax
This phase II trial tests the addition of venetoclax and/or blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged [R]) or without a KMT2A gene rearrangement (KMT2A-germline [G]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax and/or blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and/or blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL.
A Phase 2 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Patients with Stage 4 Non-Small Cell Lung Cancer
This study aims to see how well a new drug, EIK1001, works when given with pembrolizumab and certain chemotherapies in patients with Stage 4 lung cancer who haven't had other treatments. Patients will getEIK1001 through an IV once a week, and pembrolizumab every three weeks for up to 35 cycles. There are two groups: one will get EIK1001 with pemetrexed and carboplatin, and the other with paclitaxel and carboplatin. At first, a small number of patients will get a low dose of EIK1001 to check for serious side effects. If it’s safe, more patients will get a higher dose. The main goal is to see if the treatment has few side effects. The study will also look at how well the treatment works against the cancer, how long patients live without the cancer getting worse, and other important health markers. Patients will have regular scans to check their cancer and will be watched closely for side effects. The treatment will continue until the cancer worsens, side effects are too severe, or other reasons the study teams decides is good enough for patient withdrawal. After treatment ends, patients will be followed for at least 90 days to monitor their health.