Telford

Researchers are evaluating the safety, tolerability, and blood sugar control effects of ersodetug when added to standard treatments in patients with Tumor Hyperinsulinism (Tumor HI). This condition involves low blood sugar caused by hormone overproduction from tumors that cannot be removed or adequately treated with current therapies. The study is a Phase 3 trial including about 16 participants diagnosed with insulin- or IGF-producing tumors. Participants will receive weekly doses of ersodetug at 9 mg/kg along with their usual hypoglycemia treatments for 8 weeks. The study is organized into three periods: up to 4 weeks of screening, 8 weeks of treatment, and then either a follow-up period lasting up to 20 weeks after the last dose or an optional open-label extension phase lasting up to 3 years. The trial is conducted at 10 to 15 sites across approximately 5 countries. Throughout the study, participants will be closely monitored for changes in their glucose infusion needs, which is the primary measure of treatment effect after 8 weeks. Researchers will also assess safety and tolerability during and after treatment. The study involves biochemical tests, clinical evaluations, and continuous monitoring to ensure participant well-being and collect data on treatment response and side effects during the follow-up or extension phases.

Researchers are evaluating the anti-cancer effects of inobrodib combined with pomalidomide and dexamethasone in patients with multiple myeloma that has returned after treatment and no longer responds to available therapies. This Phase II, open-label, multicenter study focuses on patients who have relapsed or refractory multiple myeloma and have previously been treated with proteosome inhibitors, anti-CD38 monoclonal antibodies, pomalidomide, and bispecific T-cell engagers. The study also aims to better understand the side effects of inobrodib when used with these other medications. About 100 patients will receive 20 mg of inobrodib orally twice daily for 4 days followed by 3 days off in each 28-day cycle. Pomalidomide will be taken at 4 mg orally once daily from Day 1 to Day 21 of each cycle, and dexamethasone will be taken at 40 mg orally once daily on Days 1, 8, 15, and 22 of each cycle. Treatment continues until the disease progresses, unacceptable side effects occur, a new cancer treatment starts, or withdrawal criteria are met. Participants will be regularly monitored to assess the objective response rate, which is the percentage of patients whose disease improves according to standard criteria, until disease progression or death for up to 48 months. Researchers will also evaluate safety and side effects throughout the study. Assessments include physical exams, lab tests, and review of medical status to ensure treatment compliance and participant well-being during the study period.

Researchers are evaluating the effects of two different default dialysate sodium concentrations, 137 mmol/l and 140 mmol/l, on major cardiovascular events and death in adults receiving maintenance haemodialysis. This pragmatic, cluster-randomised, open-label study takes place in real-world dialysis sites and aims to compare the outcomes associated with these sodium levels over an extended period. The study focuses on patients with end-stage kidney disease undergoing regular haemodialysis treatment. Dialysis sites are randomly assigned to use either a default dialysate sodium concentration of 137 mmol/l or 140 mmol/l for at least 90% of dialysis sessions at that site. All other care practices continue as usual based on local standards. The study plans to recruit sites over 5 to 7 years, with individual follow-up lasting roughly 2 to 5 years. Site participation requires consent, while individual patient consent may be waived or offered an opt-out option. Participants will be monitored for major cardiovascular events and death, with the primary outcome measuring the time until the first such event occurs. Data collection methods are implemented across participating dialysis units, focusing only on in-center or satellite dialysis patients where applicable. The study's duration depends on the occurrence of endpoints, with an average follow-up of about 5 years anticipated per participant.

Researchers are evaluating the effectiveness and safety of belzutifan combined with fulvestrant compared to everolimus plus endocrine therapy in adults with estrogen receptor-positive, HER2-negative metastatic breast cancer that cannot be surgically removed. This study is a Phase 2 trial focusing on patients who have disease progression after prior endocrine therapy. The study does not include formal hypothesis testing but aims to assess these treatment combinations in this specific patient population. Participants receive either belzutifan 120 mg orally once daily plus fulvestrant 500 mg by intramuscular injection, or everolimus 10 mg orally once daily combined with the investigator's choice of fulvestrant or exemestane 25 mg orally once daily. Treatment continues in the respective groups following this dosing schedule to compare outcomes. The study is open-label and randomized across multiple centers. During the study, participants are monitored for progression-free survival up to about 29 months. Researchers will assess safety and efficacy through clinical evaluations and monitoring for adverse events. The study includes detailed eligibility screening and ongoing assessments to ensure participant safety and measure treatment effects over time.

Researchers are developing a multiomics test using the OriColTM device to analyze rectal mucus for detecting colorectal cancer and significant polyps in patients showing symptoms and referred through the colorectal urgent suspected cancer pathway. The study aims to confirm known genetic, epigenetic, and microbiome biomarkers associated with colorectal cancer and high-risk adenoma, and to discover additional biomarker signatures. It also seeks to evaluate the diagnostic performance of the OriColTM test, including its sensitivity and specificity, and to assess the health economics of delivering this diagnostic service through community diagnostic centers compared to current pathways. The study involves using the Oricol test, a diagnostic sampling device, to collect rectal mucus from patients suspected of having lower gastrointestinal cancer. This test is assessed for its accuracy in triaging patients for further colonoscopy. The study includes patients referred urgently for suspected colorectal cancer and tracks multiple biomarker signatures over a 26-month period. The research also compares diagnostic delivery methods to optimize patient care and resource use. Participants will be adults aged 18 to 99 years who have been referred on the urgent suspected cancer pathway and consent to participate. They undergo digital rectal examination and sampling using the Oricol device. Researchers will monitor biomarkers related to colorectal cancer and adenomas and measure diagnostic accuracy over the course of the study. Safety is monitored by excluding patients with conditions preventing proper examination or pregnancy. Outcome measures include biomarker presence and diagnostic test performance evaluated at 26 months.