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A Phase 1, First-in-Human Study of CND319 in Healthy Participants and Patients With Rheumatic Diseases
Expand descriptionThe purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND319 in healthy adult participants and patients with rheumatic diseases.
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Pilot Radioembolisation Clinical Trial Assessing Safety and Efficacy in Recurrent Glioma
Expand descriptionThis study is testing a new way of treating brain tumours using tiny radioactive beads called SIR-Spheres® (90Y-labelled Resin Microspheres). These microspheres are placed into the blood vessels that feed the tumour. The treatment gives off radiation inside the tumour to try to stop it from growing. This type of treatment is called Selective Internal Radiation Therapy (SIRT), Transarterial Radioembolisation (TARE), or radioembolisation. It is already an accepted treatment for patients with liver cancer. In this study, we are testing if this treatment can be done safely in the brain and how well it works.
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A Study to Investigate the Relative Bioavailability of 2 Tablet Formulations and the Effect of Food on the Pharmacokinetics of BGB-58067 in Healthy Participants
Expand descriptionThis study is being done to understand how the body processes 2 different tablet formulations of the study drug (BGB-58067) and how food intake influences the processing of the study drug by the body.
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A Clinical Study of HRS-7525 Tablets in Patients With Advanced Prostate Cancer
Expand descriptionThe purpose of this study is to evaluate the safety and tolerability of HRS-7525 in participants with Advanced Prostate Cancer, and to determine the dose limiting toxicity (DLT), the maximum tolerated dose (MTD, if possible), and the recommended Phase II dose (RP2D) of HRS-7525.
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Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer
Expand descriptionTo compare overall survival (OS) of patients in Futibatinib and Zimberelimab in Combination with Gemcitabine plus Cisplatin versus Durvalumab or Pembrolizumab in Combination with Gemcitabine plus Cisplatin for patients with first-line advanced biliary tract cancer
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DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers
Expand descriptionThis study is open to adults with advanced small cell lung cancer and other neuroendocrine cancers. The study has 2 parts. The purpose of Part 1 is to find a suitable dose of a combination study treatment, obrixtamig and ZL-1310. The purpose of Part 2 is to see how obrixtamig and ZL-1310 is tolerated when given with another medicine called a checkpoint inhibitor. Another purpose is to check whether the study treatment can stop the cancer from growing and keep it stable. Obrixtamig and ZL-1310 are being developed to help the immune system fight cancer. In Part 1, participants get obrixtamig and ZL-1310. In Part 2, participants get obrixtamig and ZL-1310 with a checkpoint inhibitor. Part 2 is only open to people with advanced small cell lung cancer. All study treatments are given as infusions into a vein. The study does not have a fixed duration. Participants can receive study treatment for up to 2 years if they benefit from treatment and can tolerate it. Participants visit the study site regularly, with some overnight stays required. During this time, doctors regularly check for health problems that could be caused by the study treatment. They also monitor the size of the tumour(s) and take laboratory tests.
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To Evaluate the Safety, Tolerability, Pharmacokinetics and the Effect of Food on the Hemay5259 Sustained-release Tablets in Healthy Subjects.
Expand descriptionEvaluation of the pharmacokinetics of Hemay 5259 sustained-release tablets in healthy human subjects
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PSTB100 Study in Healthy Adult Subjects
Expand descriptionThis study is a randomized, double-blind, placebo-controlled, dose-escalation, first-in-human clinical trial in healthy adults, designed to assess the safety, tolerability, and PK characteristics of PSTB100 tablets.
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A Single-Arm Trial of a Web-Based Acceptance and Commitment Therapy Mental Health Promotion Intervention for University Students
Expand descriptionUniversity students experience high rates of psychological distress and frequently encounter barriers to accessing professional mental health support. Web-based interventions may provide a scalable and accessible approach for promoting mental health and well-being in university settings. Acceptance and Commitment Therapy (ACT) is a transdiagnostic behavioural intervention that aims to increase psychological flexibility and has demonstrated beneficial effects on a range of psychological and academic outcomes among university students. YOLO (You Only Live Once) is a four-week, self-guided, web-based ACT mental health promotion program developed for university students. Previous pilot and randomized controlled evaluations of YOLO demonstrated significant improvements in psychological well-being, distress, and academic functioning. Following these encouraging findings, YOLO was integrated into the University of Queensland's suite of digital well-being resources for students, and the present study was designed to evaluate its university-wide implementation using a prospective single-arm interventional approach. The study aims to evaluate the preliminary effectiveness of the YOLO program in improving psychological distress, well-being, life satisfaction, academic performance, and psychological flexibility/inflexibility processes. In addition, the study will examine the feasibility, acceptability, usability, and engagement associated with participation in the intervention and investigate whether changes in psychological flexibility/inflexibility processes are associated with improvements in mental health and well-being outcomes. Findings from this study are expected to inform the future implementation and dissemination of web-based ACT interventions within university settings.
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First-in-Human Trial of VBC108 in Participants With Advanced Malignant Solid Tumors
Expand descriptionThis is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion uses Bayesian optimal interval (BOIN) design to escalate and determine the MTD and/or RP2D with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and to further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies for VBC108.