Sfax

Researchers are evaluating the pharmacokinetics, efficacy, safety, and immune response of MB12, a proposed pembrolizumab biosimilar, compared to Keytruda® in patients with advanced stage IV non-squamous non-small cell lung cancer (NSCLC). This Phase 3, randomized, double-blind study involves patients who have not received prior systemic treatment for metastatic NSCLC and includes a range of international centers. The trial focuses on patients without EGFR activating mutations or ALK translocations and measures outcomes up to 24 weeks. Participants receive either MB12, EU-sourced Keytruda®, or US-sourced Keytruda®, each given as a 200 mg intravenous infusion every 3 weeks on Day 1. These immunotherapy drugs are combined with chemotherapy agents pemetrexed (500 mg/m2 IV every 3 weeks on Day 1) and either carboplatin (area under the curve 5 IV every 3 weeks on Day 1 for 4 cycles) or cisplatin (75 mg/m2 IV every 3 weeks on Day 1 for 4 cycles). The combination treatment is administered as a first-line therapy for metastatic NSCLC. During the study, patients are monitored for drug levels in the blood, treatment effectiveness, safety, and immune response. Regular assessments include imaging to measure tumor lesions using RECIST 1.1 criteria and evaluations of overall health and organ functions. The study aims to confirm that MB12 is similar to Keytruda® in how it is processed by the body and in its treatment results. Participants are followed for at least 24 weeks to collect data on these outcomes.

Researchers are evaluating the efficacy and safety of inavolisib combined with Phesgo compared to placebo with Phesgo as maintenance therapy in participants who have previously untreated HER2-positive advanced breast cancer with PIK3CA mutations. This Phase III, multicenter, randomized, double-blind, placebo-controlled study focuses on participants with locally advanced or metastatic breast cancer, aiming to understand the treatment impact after initial induction therapy. Participants will receive inavolisib orally once daily on Days 1 to 21 of each 21-day cycle, starting on Day 1 of Cycle 1 during maintenance treatment. Phesgo will be administered subcutaneously every three weeks on Day 1 of each cycle. The study includes an induction therapy phase where taxane-based chemotherapy is given after Phesgo. Optional endocrine therapy such as tamoxifen, aromatase inhibitors, or fulvestrant may be used based on the investigator's choice, with luteinizing hormone-releasing hormone agonists administered according to local guidelines. During the study, participants will be monitored for progression-free survival for up to approximately 40 months. Assessments include evaluation of heart function, organ function, and overall health status. Researchers will track the safety and effectiveness of the treatment combination through regular clinical evaluations and laboratory tests. The total duration includes maintenance treatment cycles and follow-up to measure outcomes and monitor safety.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of ABO-101 in people with primary hyperoxaluria type 1 (PH1), a rare genetic condition. This Phase 1/2 study consists of two periods. The first period has two parts: Part A treats adults with single increasing doses to find the best dose, and Part B treats children with that chosen dose. After this, participants enter a long-term monitoring phase to meet local and national requirements. Participants receive ABO-101 through intravenous infusion. In Part A, adults aged 18 to 64 receive different single doses to identify the recommended dose. In Part B, children aged 6 to under 18 receive the recommended dose. Following these treatments, everyone is monitored long term to observe ongoing effects and safety. Throughout the study, researchers track any treatment-related side effects, including serious adverse events, for up to 6 months. Participants will undergo evaluations to assess drug safety and how their bodies process ABO-101. This monitoring helps understand the drug's impact and ensures participant safety during and after treatment.

Heart failure is a major cause of death and hospital visits in Canada, and access to specialized care varies across regions. This research aims to create and test a virtual heart failure care program that allows patients to receive outpatient treatment and medication adjustments remotely. The study compares this virtual care to usual care to see if it improves health and treatment outcomes. A pilot phase was done to test the feasibility and acceptability of the virtual care approach and to finalize study procedures. Participants will receive virtual clinic visits for three months after a hospital or emergency visit for heart failure. During this time, their physiological data will be monitored remotely, and treatments will be adjusted as needed. The trial compares this virtual care to routine heart failure care provided by the treating physician. The virtual care period represents the main follow-up for medication and health status outcomes. Throughout the study, participants will be monitored for up to 180 days to assess clinical outcomes, with primary results collected at 30, 90, and 180 days. Researchers will evaluate a combination of health and treatment measures to understand how virtual care impacts recovery after heart failure hospitalization. The study includes assessments of patient health status and ongoing monitoring of their condition during the follow-up period.