Cheongju

Researchers are conducting a 24-week observational study to monitor the safety and effectiveness of the Enerzair inhalation capsule in adults with asthma under routine clinical care. This study is prospective, open-label, multicenter, and single-arm, designed to gather real-world data without altering standard treatment practices. The goal is to evaluate how Enerzair performs in everyday use over nearly six months. Participants in this study will be adults with asthma who have already been prescribed one of two doses of Enerzair inhalation capsules via Breezhaler, following approved labeling in Korea. The two dosages used are 150/50/80 micrograms and 150/50/160 micrograms. There is no treatment assignment by the study; instead, patients continuing their prescribed Enerzair treatment will be observed. No additional diagnostic tests or monitoring beyond routine clinical care will be performed. During the 24-week study, researchers will track any adverse events or serious adverse events, including unexpected ones, to assess safety. Participants will provide informed consent for data collection. The study will observe patients through their usual care visits, focusing on safety outcomes without additional interventions or procedures. This real-world surveillance helps understand Enerzair's tolerability and safety profile over six months in a broad adult asthma population.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Chronic right ventricular pacing can negatively affect left ventricular function, leading to a condition called pacing-induced cardiomyopathy (PICM). This study aims to identify key factors from ECG, echocardiogram, or genetic tests that predict the risk of developing PICM in patients with pacemakers. By focusing on these parameters, researchers hope to improve the detection of patients at high risk for PICM and understand its long-term clinical impact. Participants will undergo ECG and echocardiogram tests, including strain measurements, before and after pacemaker implantation. The study will also examine genetic factors to better predict the occurrence of PICM. This is a prospective, multi-center observational cohort study where participants are followed over time to observe the development and outcomes of PICM. During the study, participants will be closely monitored for clinical signs of heart failure and other related complications over a period of 5 years. The main outcome measured is the diagnosis and treatment of heart failure. Researchers will use repeated heart studies and clinical evaluations to track changes in heart function and the occurrence of PICM, aiming to improve understanding of how PICM affects patient health over time.

Researchers are evaluating the efficacy and safety of benralizumab, given as a subcutaneous injection, in children and adolescents aged 6 to under 18 years who have severe eosinophilic asthma. These patients have a history of asthma exacerbations and uncontrolled symptoms despite treatment with high-dose inhaled corticosteroids plus at least one other controller medication. This Phase III study aims to compare benralizumab to placebo in reducing the time to the first asthma exacerbation. The study includes a screening period lasting from 4 to 12 weeks to confirm eligibility. After screening, patients are randomly assigned in a 1:1 ratio to receive either benralizumab or placebo via subcutaneous injections during a double-blind treatment period lasting a minimum of 16 weeks. This period continues until the patient experiences an asthma exacerbation or a set number of events occur. Patients who exacerbate can enter an open-label extension where all receive benralizumab for at least 48 weeks. An end-of-treatment visit occurs 8 weeks after the last dose in the extension phase. Participants will be monitored through visits and assessments including confirmation of severe eosinophilic asthma, asthma control questionnaires, and symptom diaries. Researchers will measure the time to first asthma exacerbation as the primary outcome. Medication adherence is tracked during screening, and safety is monitored throughout both the double-blind and extension periods. Total participation may span over a year, considering screening, treatment, extension, and follow-up visits.

This trial investigates the safety and drug-drug interaction (DDI) between DW4421 and three different nonsteroidal anti-inflammatory drugs (NSAIDs) in healthy adult volunteers aged 19 to 50 years. It is a Phase 1 clinical study focusing on understanding how these drugs interact when taken together and assessing any potential effects on the body. Participants will receive different formulations of the study drug DW4421, including once-daily (QD) and twice-daily (BID) dosing schedules. The trial evaluates the pharmacokinetics of DW4421 combined with three types of NSAIDs to monitor how the drugs are processed in the body during treatment. Volunteers will be closely monitored for drug levels and safety measures from baseline through Day 13 or Day 15, with key outcome measures including the maximum concentration (Cmax,ss) and area under the curve (AUCc4,ss) of the drugs. The study includes assessments to ensure participant health and safety throughout the trial period.

Researchers are evaluating JIN-A02, a fourth-generation EGFR-TKI drug taken orally, in patients with advanced non-small cell lung cancer (NSCLC) who have specific EGFR mutations and whose disease has progressed after standard treatments including approved EGFR-TKI therapies and limited chemotherapy. This open-label, multi-center Phase 1/2 study focuses on assessing the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of JIN-A02 in patients with EGFR mutations C797S or T790M. The study uses local testing of tumor tissue or plasma ctDNA to confirm mutation status before enrollment. The study has three parts: Part A involves dose escalation using a Bayesian Optimal Interval design to find the maximum tolerated dose (MTD) with daily oral dosing of JIN-A02 in 28-day cycles and a 21-day dose-limiting toxicity evaluation period. Part B explores two preliminary effective dose levels to determine the recommended Phase 2 dose (RP2D) with safety reviews by a committee. Part C expands dosing using the RP2D in five cohorts based on EGFR mutation types to evaluate the drug's anti-tumor activity. Dose escalation and safety are closely monitored throughout. Participants undergo regular assessments including safety evaluations, adverse event monitoring, pharmacokinetic measurements, and tumor response evaluations. The primary outcomes measured are maximum tolerable dose, adverse event rates, serious adverse event rates, and dose-limiting toxicities within specified timeframes. The study includes eligibility confirmation by local mutation testing and requires participants to have adequate organ function and performance status. Safety and benefit-risk evaluations are continuously performed by a safety review committee.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and anti-tumor activity of YH42946 in patients with locally advanced or metastatic solid tumors that have HER2 aberrations or EGFR exon 20 insertions. This phase 1/2, open-label, multicenter, first-in-human study focuses on these specific cancer types including non-small cell lung cancer and other solid tumors. The study aims to understand how YH42946 works and to find the appropriate dose for further testing. YH42946 is an oral tyrosine kinase inhibitor targeting HER2 abnormalities, including overexpression, amplification, mutation, and EGFR exon 20 insertions. The study has two parts: a dose escalation phase to determine the maximum tolerated dose and a dose expansion phase to select recommended doses for further evaluation. Several patient groups will be treated with YH42946 to assess its effects and safety. Participants will undergo assessments including monitoring for treatment emergent adverse events during the first 21 days of dose limiting toxicity evaluation and measuring objective response rates through approximately 12 months during the dose expansion part. Tumor tissue samples will be collected for mutation confirmation, and organ function will be regularly evaluated. The study includes ongoing safety monitoring and follows patients for up to about one year to evaluate treatment outcomes and side effects.

Researchers are investigating HMBD-001, an anti-HER3 antibody, in combination with cetuximab with or without docetaxel in participants who have advanced squamous cell cancers. This Phase Ib/II open-label study aims to evaluate the safety, tolerability, and efficacy of these treatments in multiple centers. The study includes participants with various advanced squamous cell carcinomas, such as lung, head and neck, esophageal, cervical, cutaneous, and nasopharyngeal cancers. Participants receive HMBD-001 intravenously once weekly alongside cetuximab weekly, which may include a loading dose on the first day of treatment. Some participants also receive docetaxel every three weeks at a dose of 60 or 75 mg/m². The study has multiple arms where treatments are given according to the participant's cancer type and prior therapies. Tumor biopsies and other assessments are part of the study requirements. During the study, participants are closely monitored for adverse events from consent until 30 days after their last dose. Safety is assessed, including dose-limiting toxicities during the first 21-day cycle. Researchers also evaluate progression-free survival for up to six months. Participants undergo regular evaluations, including tumor measurements and health assessments, to understand treatment effects and safety. The study duration varies depending on treatment response and follow-up periods.

Researchers are evaluating the safety and effectiveness of HLX22 combined with trastuzumab and chemotherapy as the first treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 2, double-blind, randomized, and multiregional study compares this combination against trastuzumab and chemotherapy with or without pembrolizumab. The study aims to measure how well the treatments work in controlling the disease and improving survival for up to five years. Participants will be randomly assigned to one of two groups. One group receives HLX22 at 15 mg/kg every three weeks along with trastuzumab, chemotherapy (XELOX regimen), and possibly a placebo for pembrolizumab. The other group receives a placebo for HLX22 plus trastuzumab, chemotherapy (XELOX), and possibly pembrolizumab every three weeks. Treatment continues until the disease worsens, unacceptable side effects occur, withdrawal of consent, or other protocol-specified reasons. Throughout the study, participants will undergo regular assessments including tumor scans reviewed by an independent committee to evaluate progression-free survival and overall survival over up to five years. Other evaluations include safety monitoring and organ function tests. The study tracks how long patients live without disease progression and overall survival, aiming to better understand the benefits and risks of HLX22 combined with current standard treatments.

Researchers are investigating how CDR132L, a potential new medicine, affects the structure and function of the heart in people living with heart failure with reduced or mildly reduced ejection fraction and left ventricular hypertrophy. This Phase 2 study compares CDR132L to a placebo, where participants receive either treatment randomly. The study aims to evaluate changes in a specific biomarker, microRNA-132-3p, over 24 weeks, with the total study duration lasting about 60 weeks. Participants will receive either CDR132L or a placebo through an intravenous infusion once every 4 weeks for a total of 48 weeks. The treatments are given under a double-blind design, meaning neither the participants nor the researchers know who receives which treatment until the study ends. This allows for a fair comparison of the effects of CDR132L versus placebo on heart structure and function. During the study, participants will undergo regular assessments including laboratory tests to measure heart-related biomarkers and imaging tests such as echocardiography to monitor heart structure and function. Researchers will track changes from baseline to week 24 in microRNA-132 levels and continue monitoring participants through the 60-week study period to evaluate safety and treatment effects. Ongoing clinical evaluations and safety checks will help ensure participant well-being throughout the trial.