Goteborg

Researchers are investigating lung mechanics in patients undergoing mechanical ventilation, focusing on the early phase from the start of ventilation until extubation. The study aims to better understand lung elastic properties and transpulmonary driving pressure using a non-invasive method called the PEEP-step method. This method measures changes in lung volume with varying end-expiratory pressure, which may help tailor ventilator settings to reduce lung injury. The research includes both intensive care patients with acute lung failure and lung-healthy patients undergoing general anesthesia for surgery. The PEEP-step method involves adjusting the positive end-expiratory pressure (PEEP) up and down in one or two steps while monitoring tidal volume and pressure changes using standard ventilator equipment linked to specialized software. This allows calculation of lung compliance and transpulmonary driving pressure without invasive esophageal pressure measurements. Measurements are taken before, during, and after respiratory treatment in intensive care units and operating rooms, including during surgery and anesthesia. The study is observational and longitudinal in design. Participants will be monitored continuously, with data collected from ventilator settings, blood gas analyses, and clinical monitoring equipment connected to a laptop for data analysis. Lung elastance changes are tracked throughout the treatment, typically over an average of one year. The study assesses lung function to find the optimal PEEP level that minimizes lung stress and aims to improve ventilator care. Consent procedures involve informing surgical patients before their operation and obtaining surrogate consent for intensive care patients.

Researchers are studying whether calderasib alone or combined with cetuximab can treat advanced solid tumors in people who have the KRAS G12C mutation. This phase 2, open-label trial aims to find out how many participants respond to these treatments and to compare their safety and tolerability. Participants receive calderasib by mouth and cetuximab through intravenous infusion. The study includes people with locally advanced or metastatic solid tumors other than colorectal cancer, who have already undergone standard treatments. The trial monitors response and side effects over time as participants receive either calderasib alone or in combination with cetuximab. During the study, participants undergo regular assessments to measure tumor response and track any side effects or adverse events. Researchers record how many people experience treatment-related side effects and how many stop treatment due to these effects. The study follows participants for up to approximately 76 months to assess long-term outcomes and safety.

Researchers are evaluating sotatercept as a potential treatment for pulmonary arterial hypertension (PAH), a condition where blood vessels in the lungs thicken and narrow, causing high blood pressure in the lungs and overworking the heart. PAH symptoms include difficulty breathing and reduced ability to be active. Current standard treatments address symptoms but do not stop disease progression. This Phase 3 study focuses on the long-term safety and tolerability of sotatercept when added to standard PAH therapy. Participants in this long-term follow-up study receive sotatercept through subcutaneous injections every three weeks. Only individuals who completed prior sotatercept PAH studies without early discontinuation may join. This study continues the observation and assessment of participants over an extended period to learn about the effects and safety of sotatercept combined with background PAH treatments. During the study, participants will be regularly monitored for adverse events, treatment discontinuations, and the presence of anti-drug antibodies for up to approximately 90 months. Laboratory tests will evaluate blood components such as platelets, hemoglobin, creatinine, bilirubin, and liver enzymes. Changes from baseline in body weight, blood pressure, and electrocardiogram readings will also be tracked. The study involves adherence to visit schedules and compliance with study procedures to ensure comprehensive long-term safety data collection.

Researchers are evaluating the safety, tolerability, and therapeutic effects of a combination treatment using BNT113 and pembrolizumab compared to pembrolizumab alone for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is positive for human papillomavirus 16 (HPV16+) and expresses the PD-L1 protein with a combined positive score of 1 or higher. This Phase II/III trial includes patients whose cancer cannot be treated with local therapies and who have not received prior systemic anticancer therapy for their current disease condition. The trial consists of two parts. Part A is a non-randomized Safety Run-In Phase to confirm the safety and tolerability of BNT113 combined with pembrolizumab at the selected dose. Part B is a randomized phase that compares BNT113 plus pembrolizumab against pembrolizumab alone as first-line treatment. Patients in Part A continue their treatment without randomization. Treatments are given by intravenous injection or infusion, and patients may receive either combination therapy or monotherapy for up to 24 months. There is also an optional pre-screening phase to test tumor samples for HPV16 DNA and PD-L1 expression before entering the main trial. Participants undergo regular assessments including tumor measurements based on RECIST 1.1 criteria confirmed by independent review. Researchers monitor treatment-emergent adverse events for up to 27 months in Part A and evaluate overall survival and progression-free survival for up to 48 months in Part B. Tumor tissue samples are collected before treatment to confirm eligibility. The study involves ongoing safety monitoring and efficacy evaluations throughout the treatment and follow-up periods.

Researchers are comparing patients with pulmonary atresia with intact ventricular septum (PA-IVS) who have either univentricular or biventricular circulation. The study aims to understand differences in mortality, quality of life, comorbidity, heart function, and work capacity between these two groups. Participants will complete a Quality of Life questionnaire. A selected group of participants, based on where they live, will be invited to undergo several tests including exercise and breathing tests (ergo-spirometry), heart ultrasounds (transthoracic echocardiogram), heart MRI scans, and blood tests to assess heart function and health. The study will measure and compare comorbidity between the two patient groups by September 2024. Participants' heart health and quality of life will be closely monitored through questionnaires and clinical examinations. The study includes individuals aged 15 years and older, and also incorporates data on those who died after turning 15.

Researchers are investigating BGB-16673, a targeted protein degrader aimed at treating various B-cell cancers including marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, Waldenström macroglobulinemia, and diffuse large B-cell lymphoma. The study includes both Phase 1 and Phase 2 parts to determine safe and effective dosing and to evaluate the drug's response in patients. The trial is conducted under the new company name BeOne Medicines, previously known as BeiGene. The treatment involves oral administration of BGB-16673. Phase 1 focuses on dose escalation and safety expansion to identify the maximum tolerated dose and recommended dose for expansion over approximately 28 days to 3 years. Phase 2 includes expansion cohorts to assess overall response rates over about 3 years. Participants may have prior treatments including Bruton tyrosine kinase inhibitors and other anticancer therapies depending on their cancer type and study phase. Participants will be monitored closely with assessments of adverse events from the first dose until 30 days after the last dose or before starting new therapy, whichever comes first, for up to 47 weeks. The study measures tolerability, dosing recommendations, and treatment response. Eligibility assessments include performance status and measurable disease, with safety and response evaluations continuing through both phases for up to three years.

Researchers are conducting a first-in-human, open-label, phase 1 trial to evaluate the safety, tolerability, and distribution of a drug called [177Lu]Lu-ABY-271 in patients with HER2-positive metastatic breast cancer. This trial involves subjects with advanced, unresectable breast cancer that overexpresses the HER2 protein, and aims to study how the drug behaves in tumors and critical organs. The trial has two parts: Part A will enroll up to 6 subjects sequentially to study the uptake of [177Lu]Lu-ABY-271 in tumors and organs. In Part B, 15 subjects will be randomized into three groups receiving different protein mass doses of the drug, divided into two cohorts with varying radioactivity levels, to determine the best dosing for future trials. Each participant receives a single infusion of [177Lu]Lu-ABY-271. Participants will be monitored from baseline through to the end of the trial, which is Day 29 for Part A and Day 43 for Part B. Researchers will assess treatment-emergent adverse events and dose-limiting toxicities during this period. Subjects will undergo evaluations to measure drug biodistribution and safety, including tumor response and any side effects related to treatment.

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.

Researchers are investigating new treatments for children and young people with relapsed or refractory B-cell non-Hodgkin Lymphoma (B-NHL), a type of cancer affecting lymph nodes and organs like the liver or spleen. Current treatments have limited success and many side effects, curing only about 30% of patients. This global trial aims to find better and safer medicines by testing novel agents in this rare cancer setting, using an adaptive trial design that allows continuous evaluation and adjustment. The trial has three treatment groups, each testing a different new medicine: bispecific antibodies (BsAbs), antibody-drug conjugates (ADC) combined with standard chemotherapy, and chimeric antigen receptor (CAR) T-cells. Patients may be assigned to any available group they qualify for, and if a treatment does not work, they might switch to another group. The trial uses a Bayesian adaptive design to efficiently decide whether a treatment is effective and can stop ineffective treatments early to introduce new ones. Participants will receive the assigned treatments and be monitored closely through scans, biopsies, and laboratory tests to evaluate disease response and safety. The main outcomes include measuring objective responses and complete remissions at specified time points. Children and young people will be followed for at least two years after treatment to monitor for side effects and long-term health. The study includes comprehensive assessments and is conducted across multiple international centers.

This research aims to collect long-term safety and effectiveness data for participants treated with ibrutinib, a medicine used for various blood cancers and conditions including Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Waldenstrom Macroglobulinemia, and Chronic Graft Versus Host Disease. It also provides ongoing access to ibrutinib for participants who have completed previous ibrutinib studies, continue treatment, and benefit from it. This is an open-label Phase 3b study without formal hypothesis testing. Participants will continue their current ibrutinib dosing regimen from the prior study, taken orally once daily as capsules in doses of 560 mg, 420 mg, 280 mg, or 140 mg, around the same time each day. Treatment continues until the investigator decides the participant no longer benefits due to disease progression or side effects, the participant withdraws, alternative ibrutinib access becomes available, or the study ends. Participants not able to access ibrutinib elsewhere can keep receiving the single-agent ibrutinib until all transition or stop treatment, or until the study is stopped. During the study, safety is monitored throughout and summarized, and effectiveness may be analyzed together with previous study data. The main outcome measured is the number of participants experiencing any adverse events within 30 days after the last dose or until starting another cancer treatment. Participants will undergo assessments including pregnancy testing and investigator evaluations to ensure ongoing benefit and safety. The study duration depends on when participants stop treatment or transition to other access.