Changwon Si

Researchers are investigating treatments for women with recurrent endometrial cancer that expresses different levels of the HER2 protein. The study has two groups based on the tumor's HER2 score: Cohort 1 includes patients with HER2 IHC 1+ or 2+ who have previously received immune checkpoint inhibitors and platinum-based chemotherapy, while Cohort 2 includes patients with HER2 IHC 3+. The purpose is to compare the effectiveness and safety of the investigational drug BNT323 (also called DB-1303) against chemotherapy in Cohort 1 and to evaluate BNT323 alone in Cohort 2. The study also looks at how the drug affects the immune system, the body's handling of the drug, quality of life, and potential side effects. Participants in Cohort 1 are randomly assigned to receive either BNT323 via intravenous infusion or a chemotherapy drug chosen by the investigator (doxorubicin, paclitaxel, or docetaxel if paclitaxel is unsuitable). Treatment continues until the cancer progresses, unacceptable side effects occur, or the participant withdraws consent. Those in Cohort 2 receive BNT323 alone until disease progression or other discontinuation criteria are met. The study includes a screening period, a treatment period expected to last about six months, followed by safety monitoring, efficacy follow-up, and long-term survival follow-up lasting up to approximately 53 months. During the study, participants undergo regular assessments including imaging scans to measure tumor response by RECIST criteria, safety monitoring for adverse effects, and evaluations of quality of life. Researchers also study the pharmacokinetics of BNT323 and the immune response. The main outcomes measured are progression-free survival in Cohort 1 and objective response rate in Cohort 2. Safety follow-up ensures ongoing monitoring after treatment to evaluate longer-term effects and participant wellbeing.

Researchers are evaluating Risvutatug rezetecan (Ris-Rez), a new medicine that targets specific proteins called B7-H3 on cancer cells to reduce the cancer's ability to grow and spread. This study focuses on participants with relapsed extensive-stage small cell lung cancer (ES-SCLC) who have previously received platinum-based systemic therapy combined with a PD-(L)1 inhibitor. The trial aims to compare how well Ris-Rez works versus the standard treatment topotecan in shrinking tumors or making them disappear, and whether Ris-Rez helps participants live longer. The study also assesses the safety and tolerability of Ris-Rez compared to topotecan and gathers information on side effects of both treatments. Participants will be randomly assigned to receive either Ris-Rez, administered as a biological treatment, or topotecan, given as a drug treatment. The study is a phase 3, multicenter, randomized, open-label clinical trial. Both treatments will be provided according to the study protocol, and participants will be monitored carefully throughout the treatment period. During the study, participants will undergo assessments to monitor tumor response using RECIST 1.1 criteria and overall survival for up to approximately 113 weeks. Researchers will also evaluate participants' organ function, performance status, and side effects. Safety monitoring includes checking for cardiovascular health, infections, bleeding, and lung conditions. The study requires participants to provide informed consent and comply with study procedures and restrictions throughout their involvement.

This research aims to collect and evaluate safety and effectiveness information about Jyseleca tablet (Filgotinib Maleate) at doses of 100 mg and 200 mg in Korean adults with rheumatoid arthritis or ulcerative colitis. The study focuses on tracking serious adverse events, adverse drug reactions, unexpected events, and other safety-related issues during real-world use following marketing approval in Korea. Participants will not receive any interventions as this is a non-interventional observational study. The study observes patients being treated with Jyseleca according to the Korean approved label, which includes adults with moderately to severely active rheumatoid arthritis or ulcerative colitis who have not responded well or are intolerant to prior therapies. The medication may be used alone or with methotrexate in rheumatoid arthritis, but not with biological DMARDs or other JAK inhibitors. During the study, participants will be monitored for safety outcomes such as serious and non-serious adverse events and adverse drug reactions up to 24 weeks after enrollment. Effectiveness measures include changes in disease activity scores for rheumatoid arthritis and ulcerative colitis at 12 and 24 weeks. Researchers will collect and evaluate all safety and efficacy-related information under typical use conditions in Korea.

Researchers are evaluating REGN5093 for treating advanced Non-Small Cell Lung Cancer (NSCLC) with MET alteration. The main goals are to find a safe dose, check how well the drug works to shrink tumors, and understand its safety and effects over time. This study includes two phases: Phase 1 focuses on determining a safe dosage, while Phase 2 assesses the effectiveness of REGN5093 using the dose found in Phase 1. Participants will receive REGN5093 through intravenous infusion. The study begins with dose escalation groups to find the right dose, followed by an expansion phase to further evaluate the treatment. The treatment aims to reduce or delay cancer progression while monitoring side effects, drug concentration in the blood, and response rate. During the study, participants will be closely monitored for side effects, treatment safety, and tumor response using standard criteria. Researchers will track laboratory results, serious or special adverse events, and drug levels in the blood over an average of 12 years. The study also measures how long it takes for REGN5093 to work and its effects on tumor shrinkage and overall safety.

Researchers are evaluating the effectiveness and safety of plixorafenib, an oral drug, in people aged 10 years and older who have various types of cancers with specific BRAF genetic changes. These include locally advanced or metastatic solid tumors, primary central nervous system (CNS) tumors with BRAF fusions, and rare BRAF V600-mutated tumors such as melanoma, thyroid cancer, and recurrent CNS tumors. The study is a Phase 2 Master Protocol designed to assess this targeted therapy in multiple subgroups based on tumor type and genetic profile. Participants receive plixorafenib oral tablets, and the study includes several subprotocols tailored to different tumor types and BRAF alterations. Subprotocols A, B, and C focus on tumors with BRAF fusions or rare BRAF mutations, while Subprotocol D enrolls adults aged 18 to 65 with solid tumors harboring BRAF V600E mutations not eligible for other subprotocols. Before starting treatment, participants provide tumor tissue or blood samples for genetic testing and scans to monitor tumor changes. Some subprotocols require stable or decreasing corticosteroid doses before treatment. Throughout the study, participants undergo regular evaluations including imaging scans, biopsies, and laboratory tests to assess tumor response and drug levels. The main outcomes measured are the objective response rate for most subprotocols and pharmacokinetics for Subprotocol D, with follow-up lasting up to approximately four years. Safety monitoring includes tracking adverse events and ensuring recovery from prior treatments, with additional assessments for heart function and infection status as needed.

Researchers are evaluating the recommended dosing regimen of loncastuximab tesirine in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) who have moderate or severe liver impairment. This phase 1b open-label study aims to understand how the drug behaves in the body and its safety in participants with varying levels of liver function. Participants receive loncastuximab tesirine through an intravenous infusion. The study includes groups with normal liver function, moderate hepatic impairment, and severe hepatic impairment. The dosing and safety are monitored closely to determine the best approach for those with liver issues. During the study, researchers track the number of participants experiencing dose-limiting toxicities within the first 21 days of treatment cycles, each lasting 21 days. Participants undergo regular evaluations, including physical assessments and lab tests, to monitor liver function, lymphoma status, and overall health. Safety and pharmacokinetics are observed to guide dosing recommendations.

Researchers are comparing two methods for guiding complete revascularization in patients with significant coronary artery disease undergoing percutaneous coronary intervention (PCI) using drug-eluting stents. The study evaluates anatomical guidance using quantitative coronary angiography (QCA) versus physiological guidance using fractional flow reserve (FFR) to determine which approach leads to better clinical outcomes. This open-label, randomized trial includes patients with symptomatic or ischemic evidence and coronary artery lesions suitable for PCI. Participants are randomly assigned to either the QCA-guided group, where PCI is performed on lesions with diameter stenosis of 50% or more as measured by QCA, or the FFR-guided group, where PCI is performed on lesions with FFR values of 0.80 or less. Imaging guidance during PCI is left to the operator's discretion, with routine high-pressure post-dilation recommended to optimize stent expansion. Follow-up visits occur at 1, 6, and 12 months, with continued observation up to 5 years after the initial procedure. During the study, researchers will monitor and evaluate clinical outcomes such as death, myocardial infarction, and repeat unplanned revascularization within 12 months. Participants will undergo clinical assessments at scheduled follow-ups to track safety and effectiveness. The study aims to provide insights into the best guidance strategy for complete revascularization in patients with coronary artery disease treated with drug-eluting stents.

Researchers are evaluating the use of artificial intelligence-driven angiography-based fractional flow reserve (MPFFR) compared to invasive fractional flow reserve (FFR) to guide percutaneous coronary intervention (PCI) in patients with coronary artery disease. This multi-center, randomized controlled trial aims to determine if MPFFR-guided PCI is not worse than the current standard invasive FFR-guided PCI. The study focuses on patients with chronic or acute coronary syndrome and intermediate coronary artery stenosis where the need for PCI is uncertain. The study compares two groups: one guided by MPFFR and the other by invasive FFR. Functionally significant stenosis is defined as MPFFR or FFR values of 0.80 or less. In the MPFFR group, on-site MPFFR values will guide decisions about PCI, while in the invasive FFR group, decisions will be made based on invasive FFR measurements. PCI is recommended for lesions meeting the threshold, but the final decision is left to the operators. Lesions with values above 0.80 will defer PCI. Reasons for not performing PCI when indicated will be recorded. Participants will undergo coronary angiography and physiological assessments using MPFFR or invasive FFR. Researchers will monitor major adverse cardiac events (MACE) one year after the last patient enrollment to compare outcomes. Data on clinical events, PCI decisions, and physiological measures will be collected. The trial seeks to validate MPFFR as a reliable, less invasive alternative to guide PCI, potentially improving patient comfort and procedural efficiency.

Researchers are evaluating the use of machine learning-based models derived from coronary angiography and intravascular ultrasound (IVUS) to improve decision making and stent optimization in patients with coronary artery disease. This multicenter, prospective study plans to enroll 3,000 patients from 15 centers in South Korea between January 2020 and June 2025. The study focuses on both treated coronary lesions requiring stent implantation and deferred lesions with more than 30% stenosis to assess the models' diagnostic performance and clinical impact. Participants will undergo percutaneous coronary intervention (PCI) guided by IVUS to implant stents. The study uses supervised machine learning algorithms to predict fractional flow reserve (FFR), characterize plaques, predict stent expansion, and forecast stent failure after implantation. Both culprit (treated) and nonculprit (deferred) coronary lesions will be monitored, with the primary goal of evaluating target vessel failure (TVF) related to these lesions over two years. During the study, participants will be closely followed for two years after their stent implantation. Researchers will assess clinical outcomes related to treated and deferred lesions, focusing on the occurrence of target vessel failure. The study involves detailed imaging and algorithm evaluation to determine the prognostic impact of the new AI technologies on event reduction following PCI.

Researchers are evaluating the safety and effectiveness of drug-coated balloon (DCB) treatment compared to drug-eluting stents (DES) in patients with large coronary artery disease. This international, randomized, open-label trial focuses on patients with new lesions in large coronary arteries (3.0 mm or larger in diameter). The study aims to show that DCB treatment is not worse than current-generation DES in terms of clinical outcomes for these patients. Participants will receive either treatment with the SeQuent4 Please NEO drug-coated balloon catheter or a current-generation drug-eluting stent. The treatments target new lesions in native large coronary arteries. Before randomization, lesions must be properly prepared with balloon angioplasty to meet specific criteria. The study includes follow-up visits at 30 days, 6 months, 12 months, 24 months, and 36 months to monitor patient progress. During the study, participants will be assessed for adverse clinical events occurring within one year, with safety and other clinical outcomes closely monitored. The study collects clinical evidence of angina or myocardial ischemia, and patients must be able to comply with the study schedule. The researchers will evaluate net adverse clinical events at one year to compare the two treatments' effectiveness and safety over time.