Bebington

Researchers are evaluating disitamab vedotin alone or combined with pembrolizumab to treat urothelial cancer that expresses HER2. This study focuses on participants with locally advanced or metastatic urothelial cancer that cannot be removed by surgery. It aims to assess how well the drug works and to monitor the side effects experienced by participants. Participants receive disitamab vedotin intravenously every 2 weeks, either alone or with pembrolizumab given by intravenous infusion on Day 1 of each 6-week cycle. The study includes multiple cohorts receiving different combinations or monotherapy treatments. The treatment period and monitoring last approximately 2 years, with ongoing assessments of drug effects and safety. During the study, participants undergo regular evaluations including imaging scans to measure tumor response, laboratory tests, electrocardiograms to monitor heart function, and assessments of side effects. Researchers measure treatment response using established cancer evaluation criteria and track survival and disease control over about 3 years. Participants are closely monitored for adverse effects and blood levels of the drugs to understand how the treatments behave in the body.

Researchers are evaluating the effects of a medicine called BI 764198 in adults and adolescents who have a kidney condition known as focal segmental glomerulosclerosis FSGS. This Phase 3 clinical trial aims to determine whether BI 764198 helps improve kidney function in people with primary FSGS or genetic FSGS linked to TRPC6 gene variants. The study is randomized and placebo-controlled, meaning participants are randomly assigned to receive either the medicine or a placebo, and neither the participants nor the researchers know which treatment each person receives. Participants take either BI 764198 tablets or placebo tablets once a day for up to two years, while continuing their usual medication for FSGS. The study involves two groups running in parallel. The main treatment period lasts 104 weeks about two years, during which the participants regularly visit the study site approximately every three months. Both groups are compared to see if BI 764198 affects kidney protein levels and function. During the study, participants provide urine samples regularly to assess their kidney health. Researchers measure changes in urine protein-creatinine ratio and kidney filtration rate from the start to the end of the treatment period. Questionnaires about health-related quality of life are also completed. Doctors monitor participants health and note any side effects throughout the two years. This thorough follow-up helps understand how BI 764198 impacts kidney disease and overall well-being.

Researchers are evaluating the anti-cancer effects of inobrodib combined with pomalidomide and dexamethasone in adults 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 refractory to certain prior treatments, including proteasome inhibitors, anti-CD38 monoclonal antibodies, pomalidomide, and bispecific T-cell engagers. The study also examines the side effects of this combination treatment. Participants will receive 20 mg of inobrodib orally twice daily for 4 days on and 3 days off in each 28-day cycle. Pomalidomide is administered orally at 4 mg once daily from Day 1 to 21, and dexamethasone at 40 mg orally on Days 1, 8, 15, and 22 of each cycle. Treatment continues until disease progression, unacceptable toxicity, new anticancer therapy initiation, or study withdrawal. Approximately 100 patients will be treated following this schedule. During the study, participants will be regularly evaluated for treatment response using International Myeloma Working Group criteria by an Independent Review Committee. Researchers will monitor objective response rate, duration and time to response, progression-free survival, overall survival, and side effects including adverse events and laboratory changes. Safety assessments will continue for 28 days after treatment ends, with follow-up lasting up to 48 months from enrollment.

Researchers are evaluating the effectiveness and safety of puxitatug samrotecan compared to a physicians choice of chemotherapy doxorubicin or paclitaxel in adults with advanced or metastatic endometrial cancer that has progressed after platinum-based chemotherapy and anti-PD-1anti-PD-L1 therapy. This Phase III, randomized, open-label study focuses on participants selected for B7-H4 expression and who have received no more than two prior treatments for advanced disease. Participants will be randomly assigned to receive either puxitatug samrotecan intravenously every three weeks or chemotherapy chosen by their physician. Chemotherapy options include doxorubicin given intravenously every three weeks or paclitaxel administered intravenously on days 1, 8, and 15 in a 28-day cycle. The study plans to enroll about 700 participants worldwide and compare how long participants live without cancer progression and overall survival between the two groups. During the study, participants will have regular assessments of their cancer status and quality of life. These will include imaging scans to measure tumor response and tracking of symptoms and side effects. Researchers will monitor progression-free survival, overall survival, response rates, duration of response, and time until further treatments are needed. The study will last approximately three years for outcome assessment, with safety and quality of life monitored throughout.

Researchers are studying CCS1477 inobrodib to evaluate its safety, tolerability, pharmacokinetics, and biological activity in adults with advanced blood cancers, including Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukemia, Peripheral T-cell lymphoma, and High Risk Myelodysplastic Syndrome. This Phase 12a interventional trial aims to understand how CCS1477 works alone and in combination with other drugs in these conditions. Participants receive CCS1477 as an oral capsule, either alone or combined with other medications such as lenalidomide, pomalidomide-dexamethasone, bortezomib-dexamethasone, ixazomib-dexamethasone, elranatamab, teclistamab, daratumumab, azacitidine, and venetoclax. Treatment involves dose escalation and expansion phases with various combinations tailored to specific types of blood cancers. The study is non-randomized and sequential, with participants assigned to different arms based on their disease and treatment combinations. Throughout the study, participants undergo regular assessments to monitor safety, including tracking treatment-related adverse events and laboratory abnormalities for up to 12 months. Researchers also measure response rates, duration of response, and pharmacokinetic parameters such as drug exposure over 35 days. The study involves ongoing monitoring during and after treatment to evaluate the effects of CCS1477 and its combinations in these hematological malignancies.