Bistrita

Researchers are evaluating the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate targeting EGFR and HER3 with a chemotherapy payload, compared to treatment chosen by physicians including paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine for patients with first-line metastatic triple-negative breast cancer TNBC or low estrogen receptor ER-low, HER2-negative breast cancer who cannot receive anti-PDL1 or endocrine therapies. This study includes adults with locally advanced, recurrent inoperable, or metastatic disease who meet specific eligibility criteria. Participants are randomly assigned to receive iza-bren or one of the physicians choice chemotherapy regimens. The treatments are given at specified doses on scheduled days. The study includes two phases Phase 2 to determine the recommended dose of iza-bren and Phase 3 to compare progression-free survival and other outcomes. The study will last several years, with follow-up extending up to approximately 47 months after randomization. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests, and monitoring for adverse events. Quality of life questionnaires will also be completed. Researchers will track progression-free survival, overall survival, treatment-related side effects, tumor size changes, and patient-reported outcomes to evaluate the treatments. The total participation duration may extend up to several years depending on treatment response and follow-up requirements.

Researchers are evaluating vamifeport in adults with homeostatic iron regulator gene-related hereditary hemochromatosis HFE-HH, a condition characterized by iron overload. This phase 2, multicenter, randomized, placebo-controlled, double-blind study aims to assess the effect of vamifeport on liver iron concentration using magnetic resonance imaging MRI. The study focuses on adults with confirmed HFE-HH and iron overload to explore the potential impact of the treatment. Participants are randomly assigned to receive either a low dose or a high dose of vamifeport, or a placebo, all administered orally twice daily up to 360 days. The study compares these three groups over this treatment period to evaluate the treatments effect on liver iron levels. The study includes careful monitoring and assessment of safety and efficacy throughout the treatment duration. During the trial, participants undergo regular assessments including MRI scans to measure liver iron concentration at baseline and day 360. Safety is monitored by tracking adverse events, laboratory tests, and electrocardiograms up to day 390. Additional evaluations include measurements of transferrin saturation, serum ferritin, joint pain, fatigue, and quality of life questionnaires. Blood samples are collected to measure vamifeport concentrations at specific time points. Participants are followed for a total of about 13 months, including treatment and safety monitoring periods.