Xitun District

Researchers are conducting a Phase III, randomized, open-label multicenter study to evaluate the effectiveness and safety of giredestrant compared with fulvestrant. Both drugs are combined with the investigators choice of a CDK46 inhibitor palbociclib, ribociclib, or abemaciclib in participants with estrogen receptor-positive ER, HER2-negative advanced breast cancer who have become resistant to prior adjuvant endocrine therapy. Participants will be randomly assigned to one of two groups one group will receive giredestrant 30 mg orally daily on Days 1-28 of each 28-day cycle, while the other will receive fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and Day 1 of subsequent 28-day cycles. Both groups will also receive a CDK46 inhibitor chosen by the investigator, with dosing schedules depending on the specific inhibitor selected. Preperimenopausal women and men will receive a luteinizing hormone-releasing hormone LHRH agonist during treatment. Participants will be assessed for progression-free survival over up to 5 years, with additional measures including overall survival, response rates, duration of response, clinical benefit, and quality of life. Safety will be monitored through adverse event reporting, vital signs, and laboratory tests during treatment and up to 28 days after the last dose. The study is led by Hoffmann-La Roche and aims to provide detailed information on the treatments effects in this patient population.

Researchers are evaluating the efficacy, safety, and pharmacokinetics of sefaxersen RO7434656, a new Antisense Oligonucleotide ASO therapy, in adults with primary IgA nephropathy IgAN who are at high risk of worsening kidney disease despite receiving optimized supportive care. This phase III study focuses on participants who continue to face disease progression despite standard treatments. Participants will receive subcutaneous injections of either sefaxersen or a matching placebo. The dosing schedule includes injections on Days 1, 15, and 29, followed by doses once every four weeks until Week 105. After Week 105 or the primary data cut-off, eligible participants may switch to open-label sefaxersen treatment at the investigators discretion. Throughout the study, participants will undergo assessments to measure changes in urine protein-to-creatinine ratio at Week 37, kidney function eGFR slope at Week 105, and monitor for hematuria resolution, kidney failure events, fatigue, and treatment-emergent adverse events. Blood samples will be collected to measure plasma sefaxersen levels. The total study duration extends up to approximately 36 months, with ongoing safety and efficacy monitoring.

Researchers are studying ZE46-0134, an investigational oral drug, in adults with relapsed or refractory acute myeloid leukemia AML who have specific gene mutations in FLT3 or spliceosome genes. This Phase 1, open-label study aims to assess the drugs safety, how it moves and works in the body pharmacokinetics and pharmacodynamics, and its preliminary effectiveness. AML is a serious blood cancer with poor survival rates, and mutations in FLT3 are common and contribute to disease progression. The study is divided into two parts Part 1 focuses on dose escalation to find the maximum tolerated dose, enrolling small groups of patients with either FLT3 or spliceosome mutations to receive up to 24 cycles of daily oral ZE46-0134 capsules. Part 2 involves dose expansion, with up to 30 patients in each mutation group receiving doses determined from Part 1. If patients benefit after 24 cycles, continuing treatment may be considered. Participants will undergo regular assessments including laboratory tests, safety monitoring, and pharmacokinetic sampling during the treatment cycles. Researchers will track adverse events, blood test results, and leukemia response up to six treatment cycles and beyond. The main outcome measured is the rate of dose-limiting toxicities during treatment, helping to evaluate the drugs safety profile. The study is expected to continue until December 2027.