Bristol

Researchers are evaluating the safety, tolerability, and effectiveness of EIK1001 combined with standard treatments in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received vein-based treatment for their advanced disease. This phase 2, open-label, multicenter trial includes participants with confirmed stage 4 squamous or non-squamous NSCLC without mutations suitable for first-line targeted therapy. The study aims to find appropriate dosing and monitor adverse events alongside treatment response. Participants receive EIK1001, a Toll-like receptor 7/8 agonist, together with pembrolizumab, a PD-1 inhibitor, and chemotherapy drugs such as paclitaxel, pemetrexed, or carboplatin. These treatments are combined as part of the standard care for stage 4 NSCLC. The trial assesses safety and efficacy over the treatment period, including a dose-finding phase to determine the best dose of EIK1001. During the study, participants undergo regular assessments including tumor measurements based on RECIST 1.1 criteria, organ function tests, and monitoring of performance status. Researchers track the percentage of participants experiencing safety events throughout up to two years of treatment. Follow-up includes ongoing evaluation of side effects and effectiveness to understand the treatment impact and participant well-being over the course of the trial.

Researchers are evaluating the safety and effectiveness of ibrutinib combined with venetoclax (I+V) and ibrutinib alone in people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This phase 2 study focuses on adjusting the ibrutinib dose either proactively or reactively based on side effects to find the best treatment approach. Participants will receive oral capsules of ibrutinib and, for some groups, oral tablets of venetoclax. The study includes different treatment groups to compare how these regimens work when ibrutinib dosing is modified in response to adverse events. Dosing schedules and adjustments will be closely monitored throughout the study. During the study, participants will undergo regular assessments including scans to measure lymph node size and other tests to track response and safety. Researchers will measure the best overall response rate for up to five years. Safety monitoring and follow-up will continue as needed to evaluate long-term outcomes and treatment tolerability.

This research aims to evaluate how well adults with new-onset generalized myasthenia gravis (gMG), who have had symptoms for less than one year, respond to treatment with efgartigimod PH20 SC. The study focuses on adults diagnosed with gMG who are seropositive for AChR antibodies and have moderate disease activity, as indicated by an MG-ADL score of 5 or higher. This phase 4, open-label study seeks to understand clinical outcomes in this specific patient group. Participants will receive subcutaneous injections of efgartigimod PH20 SC during a 51-week treatment period. The study involves a single group design without a comparator, where all enrolled subjects are treated with the study drug. The overall duration for each participant, including screening and follow-up, will be approximately 58 weeks. Throughout the study, researchers will monitor the proportion of participants achieving minimal symptom expression (MSE) of myasthenia gravis within the first 16 weeks of treatment. Participants will undergo assessments to evaluate their disease status and response to therapy over time. Safety and effectiveness will be closely observed during the treatment and follow-up periods to gather comprehensive data on participant outcomes.

Researchers are conducting a study to collect and analyze biological samples from children and adults diagnosed with various tumors, malignancies, or pre-malignant disorders, including common childhood cancers such as leukemia and tumors of the central nervous system. The goal is to develop a tissue repository and perform comprehensive molecular, genomic, proteomic, and metabolomic analyses to better understand the biology of these cancers and support the development of new therapies. Participants may have blood, serum, tissue, urine, or tumor samples collected during routine medical care or as part of approved research studies. Samples may include tumor tissue, normal tissue, and blood from patients, as well as from their biological relatives. The study involves using advanced technologies to extract DNA, RNA, and proteins, establish cell lines, and conduct immune and stromal profiling. Research tests follow approved protocols, and an oversight committee manages sample distribution. During the study, participants undergo sample collection with minimal additional risk, linked to their medical procedures or research activities. Researchers analyze tissue and fluid samples for various molecular and cellular markers, including growth factors and progenitor cells. The study includes interviews with parents or caregivers about genetic testing and incidental findings in pediatric cancer. Participants contribute to advancing knowledge over the course of their routine care and research involvement, with an expected annual enrollment of 100-150 patients.