This modular, multi-part, multi-arm, Phase 1/2, FIH study allows the evaluation of the safety and tolerability of CT7439, dosed as a monotherapy and in combination with anticancer treatment in participants with solid malignancies. Module 1 will initially focus on monotherapy in participants with locally advanced or metastatic solid malignancies and include dose escalation cohorts (Part A) and dose optimization cohorts (Part B) (Appendix A). In Parts A and B of Module 1, a SRC, consisting of study investigators and sponsor medical ...

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SAVA, a London-based bioengineering start-up company has developed 2 new CGMs, called ‘biosensors’. The ‘microsensor’ biosensor has a novel and minimally invasive design with tiny needles to reduce discomfort and pain compared to currently available CGMs. The other ‘Filament’ biosensor has a soft filament, around 5 mm, similar to other CGMs already on the market. SAVA can produce and offer both biosensors at lower cost than other currently available models on the market. The Diabetes Trials Unit, Oxford, is ...

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Radiotherapy to the chest is widely used in the treatment of lung cancer. Its use in stage IV non-small cell lung cancer (NSCLC) has evolved worldwide based on local experience, as doctors attempt to ease symptoms, maintain/improve quality of life, and prolong survival, while minimising side effects. Current palliative thoracic radiotherapy practice is still based on dose fractionations that were studied in the 1990s. However, the past 30 years have seen profound changes in the management of advanced lung cancer, ...

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Acute myeloid leukaemia (AML), is an ‘aggressive’ blood cancer with only around 20% of affected adults surviving at 5 years. AML often presents as a medical emergency and treatment is intensive. After the initial course of urgent anticancer therapy, people with AML receive repeated intensive courses of chemotherapy aimed at cure, that may include ‘haemopoietic’ (blood) stem cell transplantation. They need to remain in hospital during courses of treatment, often in isolation, due to risk of infection, with short periods ...

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1. Study design 1.1. Patient and Public Involvement (PPI) PPI remains central to this project,with the Anthony Nolan Patient Services team co-developing the proposal alongside a Patient Advisory Group (PAG). The PAG,consisting of 6 allogeneic HCT patient representatives,has been expanded to include members from underserved and minority groups to ensure diverse perspectives. PAG members actively participated in online meetings and in-person workshops,contributing to research design and sampling timepoints,providing feedback on questionnaire content and measures,and assisting in the development of patient-facing study ...

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The EXPERTS-ALS platform is designed as a randomised,open-label,multi-arm trial with a biomarker-based endpoint. It aims to prioritise drugs for further testing based on their ability to lower NFL levels and to also identify drug-specific adverse events.The EXPERTS-ALS protocol describes an overarching trial design to evaluate the effect of candidate drugs on blood NFL levels in patients with ALS receiving usual standard of care. The protocol is deliberately flexible,allowing: as broad a range of ALS patients to be recruited; participant randomisation ...

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This extension trial, 1305-0031, is aimed to assess the tolerability, long-term safety, and efficacy of BI 1015550 in patients with IPF and PPF over a longer duration of treatment. This will also fulfil a commitment to patients and the medical community to continue to provide a (potentially) beneficial treatment to trial participants after the end of their involvement in pivotal trials 1305-0014 and 1305-0023, which is important considering the progressive nature of IPF and PPF and the continuing unmet medical ...

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This study will evaluate long-term safety and efficacy in approximately 400 subjects who were dosed with SRP-9001 in a previous clinical study. The study will consist of 2 periods as follows: • An Eligibility Confirmation Visit of up to 2 days in length, during which eligibility confirmation, informed consent, disease characteristics, and current therapy/ concomitant medication data will be collected. • A Long-Term Follow-Up Period that will begin the day eligibility is confirmed and continue for at least 5 years post-infusion of ...

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The purpose of this study is to investigate if it is worthwhile prescribing medicines to reduce blood clots after varicose vein procedures. People enrolled in the study will undergo an assessment to make sure that they don’t have the most important risk factors for clots. Those most at risk would not be included in the trial. People enrolled in the study will be over 18 years of age and would receive compression stockings along with one of the following three ...

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BACKGROUND Venous thromboembolism (VTE) is a major global health burden. Many people who survive VTE suffer from longer term physical complications or psychological sequelae. Temporary lower limb immobilisation (plaster cast,walking boot or rigid splint) and injury are combined risk factors for VTE. Approximately 70,000 people are immobilised after injury every year in the UK. VTE in this setting is potentially preventable through early prophylaxis with anticoagulant medication. However,baseline VTE risk varies widely across the population and there are multiple drugs for ...

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