Beng Bu Shi

Researchers are evaluating the safety, tolerability, and effectiveness of a combination of drugs including RC118, Toripalimab, and RC148 in patients with Claudin 18.2-positive, locally advanced unresectable or metastatic malignant solid tumors, especially focusing on gastric and gastro-esophageal junction cancers. This open, multi-center study includes Phase I to establish safe dosage levels and Phase II to assess treatment outcomes. The trial is sponsored by RemeGen Co., Ltd. and aims to improve options for patients who have failed standard therapies. Participants receive RC118 administered every two weeks at one of two dose levels, combined with a fixed dose of Toripalimab every three weeks. Based on initial dose escalation results in Phase I, an extension cohort will evaluate combinations of RC118 plus Toripalimab or RC148. The study involves careful dose adjustment to find the maximum tolerated dose and recommended Phase II dose. During the study, participants will undergo regular assessments including measurement of adverse events, tumor response, and survival outcomes over up to 15 months. Tumor tissue samples will be collected to confirm Claudin 18.2 expression and monitor biomarkers. Safety monitoring includes tracking dose-limiting toxicities early in treatment and overall tolerability. Participants must meet specific health criteria and will be followed closely throughout the trial duration, with study visits scheduled to assess treatment effects and side effects.

Researchers are evaluating the effectiveness and safety of a new oral cladribine formulation in adults with Generalized Myasthenia Gravis gMG. This phase 3 clinical trial compares cladribine to a placebo to understand its sustained benefits, the need for retreatment, and long-term safety. The study also includes a component to analyze how the drug is processed in the body and features interviews to learn about participants experiences with cladribine treatment. The trial is organized into three periods a double-blind placebo-controlled DBPC period where participants receive either placebo or cladribine in two separate oral courses a blinded extension BE period where initial placebo recipients switch to cladribine doses and some receive retreatment if needed and a retreatment RT period where participants may receive additional cladribine or placebo based on clinical need. Doses include low and high oral cladribine, administered as scheduled treatment courses. Participants will undergo various assessments including evaluations of muscle weakness and daily living activities using specific scales like the MG-ADL and QMG. Researchers will monitor safety through tracking adverse events, laboratory tests, and heart monitoring. Pharmacokinetic blood sampling will measure cladribine levels at multiple time points. The study duration extends up to week 144, during which participants responses and safety are closely observed to understand the drugs effects over time.

Researchers are evaluating the efficacy and safety of angiotensin II injection compared to placebo in adult patients with refractory distributive shock. This phase III, randomized, double-blind, placebo-controlled trial aims to improve blood pressure management in patients who continue to have low mean arterial pressure despite treatment with vasoactive drugs. The study involves patients aged 18 to 75 years who have received certain vasoactive medications and meet specific clinical criteria for refractory distributive shock. Participants will be randomly assigned to receive either angiotensin II injection or a placebo through a central vein. The dosage will be adjusted based on mean arterial pressure, with allowable doses ranging from 1.25 to 160 ngkgmin, and treatment duration up to 168 hours. Both groups receive background treatment with catecholamines and other vasopressors as needed. During the study, participants will be monitored for blood pressure response at various time points after drug administration, including 1, 2, and 3 hours. Additional assessments will include organ function scores, mortality at days 7 and 28, changes in vasoactive agent doses, blood lactate levels, heart rate, and recording of adverse events over 28 days. Patients must have central venous and arterial catheters for monitoring and are expected to remain in the study for at least 48 hours of treatment evaluation.