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Found 27 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the safety and potential benefits of the investigational drug BNT329 for people with advanced solid tumors that express the tumor marker CA19-9. This Phase I/IIa study aims to find the best dose of BNT329 by tracking side effects and their severity. It also explores how well the drug works by measuring participants' tumor responses and how long the tumor stays controlled. Additionally, the study examines how BNT329 moves through and affects the body. The trial has up to four parts (A, B, C, and D). Parts A, B, and C focus on increasing doses to assess safety and tolerability in participants with various advanced cancers expressing CA19-9, including pancreatic, bile duct, bladder, colorectal, gastroesophageal junction, endometrial, and ovarian cancers. Part B tests a more frequent dosing schedule, and Part C tests pre-treatment with a CA19-9-targeting monoclonal antibody before BNT329. Part D evaluates safety and early signs of effectiveness in pancreatic cancer patients who have had prior treatments. Participants receive BNT329 through intravenous infusion. Parts A, B, and C are non-randomized, while Part D randomizes participants to two different dose levels. Participants go through screening, treatment lasting up to two years, end-of-treatment visits, two safety follow-ups, and survival monitoring until death, withdrawal, or study end. Researchers monitor side effects, serious adverse events, dose changes due to side effects, and tumor response rates over time, with follow-up periods lasting up to 36 months. Safety assessments continue up to 60 days after the last dose, and long-term survival is tracked throughout the study.

Age: 18Years +All GendersPhase 1Phase 2
10 locations
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Actively Recruiting

Researchers are studying BAY 3713372, a new drug being developed to treat solid tumors with a specific genetic change called MTAP deletion. The drug works by blocking a protein called PRMT5, which may kill cancer cells with this deletion while sparing normal cells. This first-in-human study aims to understand the safety, how the body processes the drug, and its effectiveness in people with these MTAP-deleted solid tumors. Participants will receive BAY 3713372 orally every day. The study starts with a dose escalation phase, where different groups get increasing doses to find a safe and effective dose. After this, a dose expansion phase will include more participants receiving the drug alone or with other treatments. Participants can continue treatment as long as they benefit and do not experience severe problems. During the study, participants will visit the study site multiple times before and during treatment, and follow-up visits after treatment ends. Doctors will monitor health through blood and urine tests, heart checks with electrocardiograms, and imaging scans like CT or MRI to track cancer changes. Tumor samples may also be taken. Safety and treatment response will be closely assessed, including adverse events and how the drug behaves in the body. Participants will be contacted every three months for up to two years after treatment to check their health.

Age: 18Years +All GendersPhase 1Phase 2
60 locations
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Actively Recruiting

Researchers are evaluating the effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.

Age: 18Years +All Genders
163 locations
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Actively Recruiting

This research aims to assess the effectiveness and safety of eloralintide in adults with moderate to severe obstructive sleep apnea who are also obese or overweight. The study is organized under a master protocol called YDAO, which supports two separate studies: YSA1 for participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy, and YSA2 for those who have been using PAP therapy for at least three months and intend to continue it during the study. This is a Phase 3 randomized, double-blind, placebo-controlled trial focused on this specific population. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once weekly. They will be assigned to one of two groups based on their current PAP therapy use: those not using PAP (YSA1) and those continuing PAP (YSA2). The study treatment and observation will last about 76 weeks, allowing detailed evaluation over time. During the study, participants will undergo assessments including polysomnography to measure the apnea-hypopnea index (AHI) and body weight changes from baseline to week 64. Researchers will monitor weight, sleep apnea severity, and safety throughout the trial. The long participation period includes screening, treatment, and follow-up to capture comprehensive data on eloralintide’s effects and tolerability.

Age: 18Years +All GendersPhase 3
129 locations
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Actively Recruiting

Researchers are evaluating ZW251, a new antibody-drug conjugate targeting glypican-3 (GPC3), to determine its safety and potential to treat advanced cancers including hepatocellular carcinoma (HCC), squamous cell non-small cell lung cancer (NSCLC), and germ cell tumors (GCT). This phase 1, open-label study focuses on advanced solid tumors to assess how well patients tolerate the treatment and its anti-tumor effects. The study is divided into two parts: Part 1 involves dose escalation where ZW251 is administered intravenously to find a safe and tolerable dose in patients with HCC, squamous cell NSCLC, and GCT. Part 2 focuses on dose optimization in HCC patients to further evaluate safety and possible anti-tumor activity using the recommended doses established in Part 1. Participants will undergo various assessments including monitoring for dose-limiting toxicities, adverse events, and laboratory abnormalities for up to approximately two years. The study will also measure the objective tumor response rate. Patient health status is closely tracked throughout the treatment period to assess safety and treatment effects.

Age: 18Years +All GendersPhase 1
25 locations
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Actively Recruiting

Researchers are studying the mass balance, metabolism, elimination, and drug levels of [14C]-BMS-986504 (MRTX1719) in adults with advanced solid tumors that have a specific genetic deletion called homozygous methylthioadenosine phosphorylase (MTAP) deletion. This Phase 1 study focuses on participants who have tumors that are advanced, unresectable, or metastatic and have either received or are not eligible for standard cancer treatments. Participants will receive specified doses of BMS-986504 and its radiolabeled form [14C]-BMS-986504 on designated days. The study aims to assess how the drug is processed in the body, including its metabolism and elimination over time. During the study, researchers will measure various drug levels and pharmacokinetic parameters such as maximum concentration, time to maximum concentration, drug clearance, and the amount of drug recovered in urine and feces up to two weeks after dosing. Safety and metabolism will be closely monitored throughout this period to understand the drug's behavior in the body.

Age: 18Years +All GendersPhase 1
3 locations
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Actively Recruiting

This study is a Phase IV, open-label, randomized, and multicenter clinical trial focused on patients with infective endocarditis caused by Enterococcus faecalis. It aims to evaluate whether continuous infusion of antibiotic treatment is as effective and safe as the standard intermittent treatment typically given to hospitalized patients. The study also investigates benefits such as reducing hospital stays from 4-6 weeks to about 2-3 weeks and decreasing hospital-related complications, along with secondary outcomes like mortality, serious adverse events, total days of antibiotic use, and hospitalization duration. Participants receive one of two antibiotic treatments: continuous intravenous infusion of ampicillin plus ceftriaxone for 42 days, or the standard intermittent infusion of these antibiotics for at least 14 days, followed by various possible intravenous or oral antibiotic regimens until the full 42-day treatment period is completed. The treatments are designed to compare continuous infusion with standard therapy in terms of effectiveness and safety. During the study, patients undergo follow-up visits similar to regular clinical care, with a final contact and visit occurring one year after completing the 42-day treatment. Researchers monitor clinical failure as the primary outcome, as well as safety and treatment duration. This approach allows thorough assessment of treatment outcomes and long-term patient status.

Age: 18Years +All GendersPhase 4
18 locations
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Actively Recruiting

Researchers are collecting detailed information about patients with venous thromboembolism (VTE), which includes blood clots in veins such as deep-vein thrombosis and pulmonary embolism. The project aims to improve doctors' understanding of VTE, especially in patients often excluded from clinical trials, like pregnant women, elderly individuals, cancer patients, and those with other complex health issues. The goal is to reduce deaths, clot recurrence, bleeding problems, and artery-related events by sharing this knowledge widely. The study involves gathering extensive data on each patient's health status, treatments, and outcomes during the first three months of therapy. This registry is available online to help doctors quickly find information on patients with similar medical profiles and make informed decisions about managing high-risk individuals. There are no specific interventions being tested; instead, the focus is on collecting real-world patient data. Participants provide informed consent and are followed for at least three years to monitor for new clot events and complications. Researchers track recurrences of VTE, bleeding episodes, and deaths, aiming to create tools that predict which patients are most at risk for problems. This ongoing data collection supports improving care and guiding treatment decisions for diverse patient groups over time.

All Genders
257 locations
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Actively Recruiting

Researchers are conducting an observational, multicenter epidemiological study to collect information from medical records of patients diagnosed with advanced metastatic or unresectable melanoma in Spain. The study focuses on patients with stage III or IV melanoma at their first diagnosis after January 8, 2018, aiming to describe the characteristics of this patient group without applying any experimental treatments. Participants will receive treatments determined by routine clinical practice, with no interventions or changes mandated by the study protocol. Treatment decisions are made independently of study inclusion, and no additional diagnostic or follow-up procedures beyond standard care will be applied. Patients may have received prior treatments at different hospitals, and their information will be updated across centers with appropriate consent. Throughout the study, researchers will gather data from medical records to characterize the patient population and their treatments. The main outcome measure is the sample characteristics at baseline. Patients will be tracked via assigned codes and follow-up is conducted as per usual clinical procedures, with efforts made to maintain updated information when patients transfer between centers. Participation involves consenting to data collection without additional study-related medical procedures.

Age: 18Years +All Genders
39 locations
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Actively Recruiting

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

Age: 18Years +All Genders
211 locations

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