Perai

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

This research aims to evaluate the effects of EYU688 on dengue viral load, fever clearance time, and clinical signs and symptoms in patients diagnosed with dengue fever. It is a phase 2 randomized, participant- and investigator-blinded, placebo-controlled study that investigates both the efficacy and safety of orally administered EYU688 compared with a matching placebo. The study includes two parallel cohorts with different pharmacokinetic (PK) sampling schedules: an intensive PK cohort and a sparse PK sampling cohort. Participants will receive either EYU688 or placebo capsules administered orally. The treatment is given to patients who have confirmed dengue fever symptoms and a positive dengue test, with the onset of fever within 48 hours prior to starting treatment. The two cohorts run simultaneously but differ based on the frequency and intensity of PK blood sampling to assess drug behavior in the body. Throughout the study, participants will be monitored for changes in viral load measured at 48 hours after treatment begins, as well as fever duration and clinical symptoms. Assessments include laboratory tests to evaluate safety and efficacy, with careful monitoring for any adverse effects. The total duration of participation includes screening, treatment, and follow-up evaluations to ensure comprehensive data collection on the drug's impact and participant safety.

Researchers are investigating the safety and effectiveness of Dato-DXd combined with osimertinib or alone compared to platinum-based doublet chemotherapy in treating adults with epidermal growth factor receptor-mutated (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC). This Phase III, open-label study includes participants whose disease has worsened despite prior osimertinib treatment. The goal is to evaluate progression-free survival (PFS) over up to 2.5 years. Participants are randomly assigned to one of three groups: Dato-DXd plus osimertinib, Dato-DXd alone, or platinum-based doublet chemotherapy. Dato-DXd and chemotherapy drugs (pemetrexed, carboplatin, or cisplatin) are given by intravenous infusion, while osimertinib is taken orally. Treatment continues until the cancer progresses based on imaging, unacceptable side effects occur, or other reasons require stopping treatment. After stopping the study drugs, participants will have an end-of-treatment visit within 35 days and safety follow-up about one month later. During the trial, researchers will monitor participants with radiological scans and assess progression-free survival. Safety evaluations will continue after treatment ends to detect any side effects. The study includes adults aged 18 to 130 years with good performance status and adequate organ function who have progressed on prior osimertinib therapy. The total study duration includes treatment and follow-up periods to ensure thorough assessment of treatment effects and safety.

Researchers are investigating better treatments for people with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes called HER2 mutations. Advanced NSCLC refers to lung cancers that have spread or are unlikely to be controlled with current treatments. HER2 is a protein that helps cells grow, and mutations cause abnormal HER2 leading to cancer growth. This Phase 3 study aims to compare the safety and effectiveness of a new drug, sevabertinib, against standard treatment in patients with this type of lung cancer. Participants will be randomly assigned to receive either sevabertinib tablets twice daily by mouth or standard treatment consisting of cycles of intravenous infusions including drugs like pembrolizumab, cisplatin, carboplatin, and pemetrexed every 21 days. Treatments continue as long as participants benefit without severe side effects or until they or their doctors decide to stop. Participants on standard treatment whose disease worsens may switch to sevabertinib and continue until progression, intolerable side effects, or decision to stop. During the study, participants will undergo imaging scans such as CT, PET, MRI, and X-rays to monitor cancer spread. Health checks include blood and urine tests, heart monitoring with ECG, and pregnancy tests for women. Researchers will ask about participants’ well-being and record any medical problems or side effects experienced. The main outcome measured is progression-free survival over up to about two years.

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

Researchers are evaluating an early switch from intravenous (IV) to oral antibiotic treatment for patients with uncomplicated Staphylococcus aureus bloodstream infection (bacteraemia). This phase 3, multicenter, randomized, open-label trial compares the safety and effectiveness of early oral antibiotic therapy against the standard minimum 14-day course of IV antibiotics in patients considered low-risk for complications. The study involves 290 patients from 12 Malaysian tertiary hospitals who have received 3 to 7 days of IV antibiotics. Participants are randomly assigned to either continue standard IV antibiotic treatment or switch early to oral antibiotics, including options like trimethoprim-sulfamethoxazole, clindamycin, cephalexin, or linezolid. The choice of antibiotic depends on bacterial susceptibility and patient factors. The treatment phase lasts 7 to 11 days, followed by a 90-day follow-up period with scheduled phone or inpatient visits. During the approximately 12-week study, patients undergo screening and enrollment, receive open-label antibiotic treatment, and are monitored at days 7-11, 30, and 90 after randomization. Researchers assess outcomes such as the rate of relapse of Staphylococcus aureus bacteraemia within 90 days. Patient condition reviews and standard clinical assessments are conducted to ensure safety and measure treatment effectiveness.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.

Researchers are investigating the safety, tolerability, how the body processes, immune response, and anti-cancer effects of volrustomig combined with other cancer drugs in adults with certain solid tumors, including non-small cell lung cancer (NSCLC). This Phase II, open-label, multicenter platform study focuses on evaluating these combinations in different types of NSCLC. The study includes participants with metastatic non-small cell lung cancer, divided into substudies and treatment groups based on tumor characteristics. Participants will receive volrustomig through intravenous (IV) infusion along with other anticancer drugs such as carboplatin, pemetrexed, ramucirumab, or paclitaxel, also given by IV. The study has two substudies: one for metastatic non-squamous NSCLC with randomization between two treatment arms, and another for metastatic squamous or non-squamous NSCLC enrolling in a single arm. All treatment arms test volrustomig dosing combined with chemotherapy. Throughout the study, participants will be monitored for side effects, immune reactions, and tumor responses for up to nearly three years. Researchers will track adverse events and serious adverse events from screening through the follow-up period, as well as measure objective tumor responses. The study involves regular assessments to evaluate safety, drug effects, and cancer activity during and after treatment.