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Found 40 Actively Recruiting clinical trials
Actively Recruiting
Researchers are investigating new treatments for extensive-stage small cell lung cancer ES-SCLC, a type of lung cancer that has spread widely within the lungs or to other parts of the body. This study evaluates the combination of two study medicines, gocatamig and I-DXd ifinatamab deruxtecan, with or without standard chemotherapy and immunotherapy. The research aims to understand the safety and tolerance of these combinations and whether they can shrink or eliminate tumors in people with ES-SCLC. Participants are assigned to one of several treatment groups. Some receive gocatamig and I-DXd during maintenance after completing standard chemotherapy and immunotherapy, while others receive these study medicines during both induction and maintenance phases. Additional groups receive gocatamig and I-DXd followed by gocatamig and atezolizumab, or standard treatment with carboplatin, etoposide, and atezolizumab followed by atezolizumab maintenance. Treatments are given intravenously and continue until disease progression or other study-specified criteria. During the study, participants will have regular assessments to monitor safety, side effects, and treatment response, including scans to measure tumor size and laboratory tests to evaluate drug levels and immune response. The study will track adverse events, treatment tolerability, and cancer control over up to approximately 58 months. Participants health status and responses to the treatments will be closely observed throughout this period, with periodic evaluations to understand long-term effects and outcomes.
Actively Recruiting
Researchers are evaluating the safety, effectiveness, optimal dose, and behavior of an investigational drug called BNT326, alone or combined with other immunotherapy agents, in adults with advanced solid tumors. This study includes patients with tumors that have either spread metastatic, returned after treatment, or progressed despite previous therapies, across various cancer types such as melanoma, lung cancer, breast cancer, gastric cancer, colorectal cancer, and cervical cancer. Participants are divided into two parts Part 1 tests BNT326 alone in different tumor-specific groups, some with dose randomization to find optimal dosing. Part 2 evaluates BNT326 alone or combined with another investigational drug called pumitamig in several cancer types, with some groups receiving randomized doses and others non-randomized treatments. Treatments are given via intravenous infusion, with some oral medications combined in Part 1. The study includes dose escalation and randomization phases, and treatment can continue for up to 24 months or until disease progression or other reasons. During the study, participants undergo screening, treatment, safety follow-up, efficacy follow-up, and long-term survival monitoring phases. Researchers assess adverse events, treatment responses, disease progression, and drug behavior in the body using clinical evaluations and laboratory tests. Follow-up assessments occur up to approximately 38 months for Part 1 and 48 months for Part 2, with continued treatment possible for those benefiting from the therapy. The study aims to gather comprehensive data on safety, dosing, and effectiveness in this patient population.
Actively Recruiting
Researchers are evaluating the safety and optimal dose of BNT329, an investigational drug, in people with advanced solid tumors that express the tumor marker CA19-9. The study also aims to assess how well BNT329 works by measuring participant responses and how long the tumor remains stable without growth or spread. Additionally, the study will examine how BNT329 moves through and affects the body. The trial includes up to four parts. Parts A and B focus on increasing doses to study safety and tolerability in participants with various advanced cancers expressing CA19-9 who have not responded well to previous treatments. Part C may be added if safety or effectiveness concerns arise, involving pre-dosing with a CA19-9 targeting antibody before BNT329. Part D tests two selected dose levels in participants with pancreatic ductal adenocarcinoma PDAC who have received prior treatment. Treatment is given as intravenous infusions every 2 or 3 weeks depending on the study part. Participants undergo screening, followed by treatment for up to two years, an end-of-treatment visit, two safety follow-ups, and a survival follow-up until death, withdrawal, or study end. Throughout the study, researchers monitor side effects, dose adjustments, tumor response, and survival. Blood samples will be collected to study drug levels and immune responses. Safety and effectiveness will be assessed up to 36 months from first dose.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating a mentalization-based prevention program aimed at improving well-being and mental health in children aged 8 to 10 years and their families across four European countries Germany, Lithuania, Spain, and Switzerland. The study is designed as a partially randomized controlled trial and investigates how multi-level interventions involving children, parents, and teachers can promote mental health, reduce stigma, enhance help-seeking behavior, and improve classroom climate and parenting skills. The program includes a universal prevention workshop delivered at schools for all children, focusing on mental health awareness and peer support skills. Parents receive one of two different intervention trainings or a parenting guidebook one group attends 10 weekly sessions of the Lighthouse Program targeting secure attachment and reflective parenting behaviors, and another group participates in 6 bi-weekly Mentalization Based Skills Training sessions focusing on attentional control and emotion regulation. An active control group receives a parenting guidebook, while a passive control group participates in follow-up assessments without intervention. Participants will be involved in data collection at multiple time points baseline, post-intervention at 3 months, and follow-ups at 6 and 12 months. Assessments include questionnaires measuring childrens and parents well-being and mental health, parental efficacy and stress, classroom climate, teaching efficacy, and mental health stigma. Focus groups after the post-assessment will gather feedback on implementation and satisfaction. The study aims to follow 5,000 children, their parents, and teachers over a year to evaluate long-term program effects.
Actively Recruiting
Researchers are studying the use of bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin, known as triple therapy, in adults with primary hypercholesterolemia or mixed dyslipidemia. The study aims to evaluate the effectiveness and safety of this combination in real-world clinical practice, focusing on lowering LDL cholesterol LDL-C levels. This is an observational study, meaning no drugs are administered by the study team instead, existing treatments are monitored. Participants are adults who have started triple therapy within the past four weeks and are followed for up to one year. The study looks at LDL-C changes after 8 weeks and 1 year of treatment, adherence to the therapy, side effects, and cardiovascular events such as heart attacks and strokes. No new treatments are given instead, researchers collect information on the participants ongoing treatments involving bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. During the study, participants LDL-C levels, laboratory values, and treatment adherence are regularly reviewed. Researchers will also record any adverse events and track major cardiovascular events over the year. The primary measurement is the change in LDL-C from before treatment to 8 weeks after starting triple therapy. Participants health is followed through routine clinical assessments, and the study lasts for up to one year after beginning triple therapy.
Actively Recruiting
Researchers are evaluating the efficacy and safety of eloralintide in adults with moderate-to-severe obstructive sleep apnea who are also overweight or obese. This trial is structured as a master protocol called YDAO, which supports two studies YSA1 for participants who do not use or refuse Positive Airway Pressure PAP therapy, and YSA2 for those who have been on PAP therapy for at least three months and plan to continue it. The study aims to understand how eloralintide affects body weight and sleep apnea severity over time. Participants will be randomly assigned to receive either eloralintide or a placebo through subcutaneous injections once weekly. The study includes two parallel groups reflecting current PAP therapy use. Treatment lasts about 64 weeks, followed by assessments. The design includes double-blinding to compare the effects between intervention and placebo groups. During the study, participants will be closely monitored for changes in body weight and apnea-hypopnea index AHI at baseline and week 64. Additional measurements include blood pressure, triglycerides, inflammation markers, sleep-related impairment scores, and glucose metabolism. Researchers will also track patient-reported outcomes, medication use, and pharmacokinetics. Participation lasts approximately 76 weeks, covering screening, treatment, and follow-up evaluations to ensure safety and collect comprehensive data.
Actively Recruiting
Researchers are evaluating BAY 3713372, a new drug designed to treat MTAP-deleted solid tumors by blocking a specific protein called PRMT5. This first-in-human study aims to understand how safe BAY 3713372 is, how the body processes it, and how well it works for people with these tumors. The study will monitor side effects, dosage limits, and the drugs levels in the blood over time. Participants will be grouped into eight different study cohorts. Initially, there will be a dose escalation phase where groups receive increasing doses of BAY 3713372 alone to find the safest and most effective dose. Afterward, a dose expansion phase will involve more participants receiving the drug alone or combined with other treatments. Participants may continue treatment as long as it remains beneficial without serious problems. Throughout the study, participants will visit the study site multiple times before and during treatment, with follow-up visits scheduled every nine weeks after treatment ends until cancer worsens or participation stops. Doctors will perform health checks, blood and urine tests, heart monitoring, and imaging scans like CT or MRI to assess tumor status. Tumor samples will be collected, and health updates will be gathered every three months for up to two years after the last dose or study end.
Actively Recruiting
Researchers are evaluating ZW251, an antibody-drug conjugate targeting glypican-3 GPC3, in people with advanced cancers such as hepatocellular carcinoma HCC, squamous cell non-small cell lung cancer NSCLC, and germ cell tumors GCT. The study aims to assess whether ZW251 is safe and can treat these cancers. This is a phase 1, open-label, multicenter trial sponsored by Zymeworks BC Inc. The study has two parts Part 1 focuses on dose escalation to test the safety and tolerability of ZW251 in participants with HCC, squamous cell NSCLC, and GCT. Part 2 involves dose optimization to further evaluate safety and potential anti-tumor effects of the recommended doses in participants with HCC. ZW251 is administered intravenously during the study. Participants will be monitored for dose-limiting toxicities, adverse events, laboratory abnormalities, and tumor responses for up to approximately two years. Researchers will assess tumor size changes, disease control, response duration, and progression-free survival. Blood samples will be taken to measure drug concentration and immune reactions. Safety and treatment effects will be closely followed throughout the study.
Actively Recruiting
Researchers are evaluating the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis SPMS. This is a Phase III, randomized, double-blind, placebo-controlled, multi-center study involving approximately 1275 participants. The study aims to provide important data on remibrutinibs effect on disability progression in SPMS and includes both a Core Part and an Extension Part for further assessment. Participants are randomly assigned to receive either remibrutinib or a matching placebo as oral film-coated tablets during the Core Part. The Core Part includes double-blind treatment, followed by an Extension Part where all participants receive open-label remibrutinib tablets. Treatment is taken orally, and the study is event-driven, continuing until required endpoints are met. During the study, participants undergo regular assessments of disability progression using the Expanded Disability Status Scale EDSS, Timed 25-Foot Walk, 9-Hole Peg Test, and Symbol Digit Modalities Test, among others. Brain imaging and safety monitoring for adverse events are performed throughout up to approximately five years. Researchers track changes in brain lesions and atrophy, and follow participants for safety and treatment effects over time.
Actively Recruiting
Researchers are evaluating 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 understanding how this drug behaves in the body of participants whose cancers have this genetic feature and who have limited treatment options. The study has two parts In Part A, participants receive a single oral dose of radiolabeled 14C-BMS-986504 to track the drugs movement and breakdown in the body. In Part B, participants receive non-radiolabeled BMS-986504 starting from the first day of the cycle until criteria for stopping treatment are met. This approach helps researchers observe drug levels and effects over time. Participants will undergo various assessments including blood and urine tests up to two weeks after dosing to measure drug concentration, elimination, and distribution. Researchers will also monitor safety by tracking adverse events and laboratory abnormalities for up to two years. The study aims to gather detailed pharmacokinetic data and observe any side effects during and after treatment.
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