Cheongju

Researchers are evaluating new treatments for locally advanced non-small cell lung cancer NSCLC that cannot be surgically removed and has a specific gene mutation called KRAS G12C. This trial aims to find out if the combination of calderasib MK-1084 and durvalumab can help participants live longer without their cancer growing or spreading compared to durvalumab with a placebo after they have completed chemotherapy and radiation therapy. Participants will be randomly assigned to receive either calderasib along with durvalumab or a placebo along with durvalumab. Calderasib is taken by mouth as a tablet, and durvalumab is given as an intravenous infusion. This study is double-blinded, meaning neither the participants nor the researchers know who receives the active drug or placebo. The treatment period will be followed by long-term monitoring. During the study, participants will have various assessments including survival monitoring up to approximately 9 years, evaluations of adverse events, response rates, and quality of life questionnaires. Researchers will also collect tumor tissue samples for biomarker analysis. The main measurement is progression-free survival, checked for up to about 6 years. Participants health and side effects will be closely tracked throughout and after treatment.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with platinum-based chemotherapy as a first treatment for patients with locally advanced or metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1. This Phase III global study focuses on patients with PD-L1 tumor cell expression of 1% or higher and aims to determine which treatment provides better overall and progression-free survival. Participants will be randomly assigned to one of two study groups one group will receive rilvegostomig plus carboplatin and either paclitaxel or nab-paclitaxel chemotherapy, while the other group will receive pembrolizumab plus the same chemotherapy options. Rilvegostomig and pembrolizumab are both given intravenously on Day 1 of each 21-day cycle, with chemotherapy given up to 4 cycles. Nab-paclitaxel may be administered on Days 1, 8, and 15 of each cycle. Treatment continues with rilvegostomig or pembrolizumab until disease progression or other criteria are met. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests to monitor organ function, and patient questionnaires about physical function and quality of life. Researchers will track overall survival, progression-free survival, response rates, and duration of response for up to approximately 6 years. Safety and immune response to rilvegostomig will also be evaluated. Participants will be closely monitored throughout the treatment and follow-up periods.

Researchers are studying pacing-induced cardiomyopathy PICM, a condition where chronic right ventricular pacing harms left ventricular function. This observational study focuses on ECG and echocardiogram parameters, including strain, as well as genetic factors, to identify patients at high risk of developing PICM after pacemaker implantation. The goal is to better predict who might develop PICM and understand its clinical impact over time. Participants will have ECG and echocardiogram tests before and after pacemaker implantation to assess key measurements such as QRS duration and mechanical strain. Genetic factors may also be evaluated to improve prediction of PICM occurrence. This study involves long-term follow-up to monitor the condition and its outcomes. During the study, participants will be clinically followed for up to 5 years to observe heart failure diagnosis and treatment. Researchers will also track atrial and ventricular arrhythmias, hospital admissions for heart failure, and overall mortality. The study does not involve treatment interventions but focuses on monitoring and data collection to understand PICM and its clinical outcomes.

This trial investigates the safety and drug-drug interaction between DW4421 and three different nonsteroidal anti-inflammatory drugs NSAIDs in healthy adult volunteers. The study is a Phase 1 clinical trial designed to assess how these drugs interact in the body, focusing on their pharmacokinetics, which helps understand the drug levels and behavior over time. Participants will receive different forms of the investigational drug DW4421, administered once daily or twice daily depending on the variant DW4421, DW4421-N1, DW4421-N2, DW4421-N3. The study is randomized and includes several cohorts to evaluate these combinations carefully. Each participant will follow specific dosing schedules during the trial. During the trial, researchers will monitor participants closely through various assessments including measuring drug concentration peaks Cmax and overall exposure AUC from baseline to study days 13 or 15. Healthy volunteers aged 19 to 50 will be observed for any safety concerns or changes in how the drugs work together. The total study participation lasts from the start until the final assessments around day 15, with continuous monitoring of drug interactions and safety.

Researchers are evaluating the safety, tolerability, how the body processes and responds to the drug, and the anti-tumor activity of BGB-B2033 alone and in combination with tislelizumab, with or without bevacizumab. This first-in-human study focuses on participants with locally advanced or metastatic solid tumors including hepatocellular carcinoma, alpha-fetoprotein-producing gastric cancer, extragonadal yolk sac tumors, and glypican-3-positive squamous non-small cell lung cancer. The trial aims to determine safe dosage levels and preliminary effectiveness in these advanced cancer types. Participants receive intravenous infusions of BGB-B2033 either alone or combined with tislelizumab and bevacizumab in several dose escalation and expansion cohorts. The study includes ascending doses of BGB-B2033 monotherapy, combination therapies to find maximum tolerated doses and recommended doses for further testing, and safety expansion groups. Some participants are from Asian countries and others from the United States, focusing on hepatocellular carcinoma in these regions. Throughout the study, participants are closely monitored for adverse events and responses to treatment for up to approximately 2 years. Assessments include safety evaluations, measuring tumor responses by independent review and investigators, pharmacokinetic and pharmacodynamic tests, and antibody development against the study drug. Tumor tissue samples are required for certain parts of the study. This comprehensive follow-up helps researchers understand the study drugs activity and safety in advanced cancers.

Researchers are evaluating JIN-A02, a fourth-generation EGFR-TKI oral medication, in people with advanced non-small cell lung cancer NSCLC that has specific EGFR mutations and has progressed after standard treatments. This Phase III open-label study focuses on assessing the safety, tolerability, pharmacokinetics, and anti-tumor activity of JIN-A02 in those who have previously received approved EGFR-TKI therapy andor platinum-based chemotherapy. The study includes multiple parts to explore dosing and treatment effects based on mutation types. The study has three parts Part A is a dose escalation phase using a Bayesian Optimal Interval design to find the maximum tolerated dose MTD in patients with EGFR mutations C797S or T790M. JIN-A02 is given once daily in 28-day cycles, with dose adjustments based on safety evaluations. Part B further explores two selected dose levels to determine the recommended Phase 2 dose RP2D. Part C expands treatment to five cohorts defined by specific EGFR mutation profiles, monitoring anti-tumor activity using the established RP2D. Participants undergo regular assessments including safety reviews by a committee, tumor mutation testing from tissue or plasma samples, and monitoring for adverse events and dose-limiting toxicities. The study measures outcomes such as maximum tolerated dose, adverse event rates, and dose-limiting toxicities over specified timeframes. The study duration and follow-up depend on the dose-escalation, exploration, and expansion phases with ongoing data collection for safety and benefit-risk analysis.

Researchers are evaluating YH42946, a new oral drug that targets HER2 and EGFR exon 20 insertions in patients with locally advanced or metastatic solid tumors. This Phase 12, open-label, multicenter study aims to assess the safety, tolerability, how the body processes the drug, and its anti-tumor activity. The study is sponsored by Yuhan Corporation and focuses on patients whose tumors have specific genetic changes involving HER2 and EGFR. The study has two parts. The first part involves gradually increasing doses of YH42946 to find the highest dose patients can tolerate safely. The second part expands the study to test selected doses in several patient groups to determine the recommended dose for future studies. Participants will receive YH42946 orally as the investigational treatment throughout these phases. Participants will undergo regular assessments including monitoring for side effects during the first 21 days, and evaluation of tumor response over about 12 months. Researchers will collect blood samples to study how the drug moves through and affects the body. Safety and treatment effects will be closely tracked to guide dosing decisions and understand the drugs impact. The total study duration varies depending on individual participation in dose escalation and expansion phases.

Researchers are evaluating HMBD-001, an anti-HER3 antibody, in combination with cetuximab with or without docetaxel for people with advanced squamous cell cancers. This Phase IbII, open-label, multi-center study focuses on various types of advanced or metastatic squamous cell carcinomas, including lung, head and neck, esophageal, cervical, cutaneous, and nasopharyngeal cancers. The study aims to assess the safety and effectiveness of these treatments in participants who have limited standard care options. Participants receive HMBD-001 intravenously once a week alongside cetuximab weekly, with or without docetaxel administered every three weeks. There are three treatment arms one with HMBD-001 plus docetaxel, one with HMBD-001 plus docetaxel and cetuximab both closed to recruitment, and one with HMBD-001 plus cetuximab. The trial evaluates different combinations to understand their effects on advanced squamous cell cancers. During the study, participants are monitored for adverse events and dose-limiting toxicities. Researchers track progression-free survival up to six months and measure tumor response using established criteria. Blood samples are collected to study the drugs behavior in the body and immune response. The study includes repeated treatment cycles and safety follow-up, with assessments continuing up to 48 months. Participants undergo tumor biopsies and organ function tests to ensure safety and gather comprehensive data.

Researchers are evaluating HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are evaluating a potential new medicine called CDR132L to understand its effects on the structure and function of the heart in people living with heart failure. The study focuses on participants with heart failure who have reduced or mildly reduced ejection fraction and left ventricular hypertrophy. This research is a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial aiming to assess safety and efficacy in this population. Participants will receive an intravenous infusion of either CDR132L or a placebo once every four weeks for 48 weeks. Alongside this, all participants will continue their individually tailored guideline-directed standard of care therapy for heart failure. The studys main phase covers these 48 weeks of treatment, followed by monitoring adverse events up to week 60. During the approximately 60-week study, participants undergo evaluations including echocardiography and blood tests measuring biomarkers like microRNA-132-3p and NT-proBNP. Researchers will track changes in heart structure and function, adverse events, and safety throughout the study. The primary outcome focuses on changes in normalized microRNA-132-3p levels from baseline to week 24, while secondary outcomes include measures of heart volume and biomarkers, plus adverse event counts.