Changwon Si

Researchers are evaluating the effectiveness and safety of an investigational drug called BNT323 also known as DB-1303 compared with standard chemotherapy in women with recurrent endometrial cancer. The study includes two groups based on the level of HER2 protein in the tumor Cohort 1 with HER2 levels 1 or 2 who have been previously treated with immune checkpoint inhibitors, and Cohort 2 with HER2 level 3. The study aims to understand how well BNT323 or chemotherapy controls cancer progression and how the drug affects patients immune response and quality of life. Participants in Cohort 1 will be randomly assigned to receive either BNT323 or chemotherapy drugs such as doxorubicin, paclitaxel, or docetaxel. In Cohort 2, participants will receive BNT323 alone. Treatments are given intravenously and continue until the cancer progresses, unacceptable side effects occur, or consent is withdrawn. The study includes screening, treatment, safety follow-up, efficacy follow-up, and a long-term survival follow-up lasting up to about 53 months. During the study, participants will undergo regular assessments including tumor evaluations, safety monitoring, and quality of life questionnaires. Researchers will measure progression-free survival in Cohort 1 and tumor response rate in Cohort 2. Safety is monitored by tracking adverse effects and drug levels in the body. Participants can expect to be followed for up to 53 months after treatment to assess long-term outcomes and survival.

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 evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating Risvutatug Rezetecan Ris-Rez, a new medicine targeting specific proteins on cancer cells, in adults with relapsed extensive-stage small cell lung cancer ES-SCLC. This phase 3 study aims to compare how well Ris-Rez works versus the standard treatment, topotecan, by measuring cancer shrinkage, disappearance, and overall survival. The study also monitors safety, side effects, and tolerability of both treatments. Participants will be randomly assigned to receive either Ris-Rez or topotecan. Both treatments will be administered as part of the study to assess their effects. The study will follow participants for up to approximately 139 weeks to evaluate multiple outcomes including survival, tumor response, disease progression, and brain metastasis control. During the study, participants will have regular evaluations including scans, laboratory tests, vital signs, electrocardiograms, and performance status assessments. Researchers will track adverse events, laboratory changes, and participant experiences with the study drugs. The main outcome measured is overall survival up to about 113 weeks, with additional long-term monitoring of other health and disease measures throughout the study.

This research aims to collect and evaluate safety and effectiveness information about Jyseleca tablet Filgotinib Maleate 100 mg and 200 mg in Korean participants using it in real-world conditions. The study focuses on monitoring serious and non-serious adverse events and drug reactions, including unexpected ones, as well as changes in disease activity scores related to rheumatoid arthritis and ulcerative colitis. Participants prescribed Jyseleca according to Korean approved therapeutic indications will be observed without additional intervention. They will be followed for up to 24 weeks or until they stop treatment due to adverse events or other reasons. The study includes adults with rheumatoid arthritis or ulcerative colitis who have not responded well or are intolerant to prior treatments. During the study, researchers will track adverse events and reactions from enrollment through 24 weeks. They will also measure changes in disease activity scores at baseline, week 12, and week 24. Participants will have regular monitoring visits as part of their usual care, with data collected about safety and treatment effects. The total participation time is up to 24 weeks.

Researchers are studying two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 genetic mutations. This trial compares bilateral salpingectomy, which removes only the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The goal is to find out if removing just the fallopian tubes with delayed ovary removal is nearly as effective as removing both from the start. Participants choose between two groups one undergoes bilateral salpingectomy with the option of later ovary removal, and the other undergoes bilateral salpingo-oophorectomy. Both groups have imaging tests like pelvic ultrasounds or pelvic MRIs during screening and provide blood samples throughout the study. Follow-up visits occur at multiple time points, including 10 to 60 days, 6 months, 12 months, 24 months, and then yearly for up to 20 years. During the study, researchers track if ovarian or related cancers develop and assess symptoms related to estrogen loss, quality of life, cancer-related distress, sexual function, menopausal symptoms, medical decision making, and any adverse events. Various questionnaires and imaging tests support these evaluations. Long-term safety and cancer risk reduction are monitored for up to two decades after surgery.

Researchers are evaluating the effectiveness and safety of combining standard chemotherapy and bevacizumab with or without the drug INCA33890 for the first treatment of metastatic microsatellite stable colorectal cancer. This is a Phase 3 randomized trial focusing on patients with stage IV colorectal adenocarcinoma that cannot be cured by surgery. Participants receive either INCA33890 or a placebo, both given alongside bevacizumab and FOLFOX chemotherapy at doses defined by the study protocol. Treatment is administered as part of the first-line therapy for metastatic disease, with participants randomly assigned to one of the two groups. During the study, participants will be regularly monitored through imaging and clinical assessments to measure progression-free survival for up to three years. Additional outcomes include overall survival, response to treatment, side effects, and quality of life measures up to four years. Safety and treatment effects will be closely followed throughout the trial period.

Researchers are evaluating two different strategies for complete revascularization in patients with significant coronary artery disease CAD who are undergoing percutaneous coronary intervention PCI with drug-eluting stents DES. The study compares quantitative coronary angiography QCA-guided anatomic complete revascularization and fractional flow reserve FFR-guided physiologic complete revascularization. This prospective, multicenter, randomized trial includes patients with symptoms or evidence of myocardial ischemia and specific stenotic lesions in major coronary arteries. Participants are randomly assigned to either the QCA-guided group, where PCI is performed on lesions with at least 50% diameter stenosis, or the FFR-guided group, where PCI targets lesions with FFR values of 0.80 or less. Imaging guidance during PCI is optional but left to the operators discretion, while routine high-pressure post-dilation is recommended. The study involves an initial procedure with possible staged procedures as needed. Participants will be followed clinically at 1, 6, and 12 months, and then up to 5 years after the initial procedure. Assessments include tracking death, myocardial infarction, unplanned repeat revascularization, bleeding, rehospitalization, and self-rated health. The study aims to collect data on these outcomes to compare the two revascularization strategies in terms of safety, efficacy, and cost-effectiveness over both short- and long-term periods.

Researchers are evaluating the use of an artificial intelligence-driven angiography-based fractional flow reserve MPFFR compared with 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 inferior to invasive FFR-guided PCI in terms of clinical outcomes. The study addresses limitations of current FFR methods, such as the need for pressure wires and drug-induced hyperemia, by testing a faster, automated AI-based alternative. Participants will be randomly assigned to one of two groups the MPFFR-guided PCI group or the invasive FFR-guided PCI group. In the MPFFR group, AI software analyzes angiographic images to measure blood flow reserve without manual segmentation, with PCI recommended for lesions showing MPFFR values of 0.80 or less. In the invasive FFR group, a pressure wire and drugs are used to measure FFR, with PCI recommended for lesions with FFR values of 0.80 or less. Decisions to perform PCI are made by the treating doctors, and reasons for deferral are recorded. During the study, participants will undergo diagnostic coronary angiography followed by the assigned FFR measurement method. Researchers will monitor major adverse cardiac events one year after the last patient enrolls, along with other outcomes such as death, heart attacks, revascularization procedures, and procedure-related measures. The trial includes detailed follow-up to assess safety and effectiveness, with data collected on procedure times, contrast use, and device performance throughout the study period.

Researchers are evaluating the effects of aspirin and high-intensity statin therapy in people with severe coronary calcification, defined as a coronary calcium score of 300 or higher. The trial aims to understand how these treatments may help prevent atherosclerotic cardiovascular disease ASCVD events in this population. This phase 4, randomized, open-label trial uses a factorial design to assess both aspirin use and statin intensity. Participants are assigned to one of four groups aspirin 100 mgday with high-intensity statin therapy no aspirin with high-intensity statin therapy no aspirin with guideline-directed statin therapy or aspirin 100 mgday with guideline-directed statin therapy. Statin intensity follows the 2026 ACCAHA Guideline on the Management of Dyslipidemia. The study treatment lasts for 3 years, during which participants take the assigned medications. Throughout the trial, participants will be monitored for cardiovascular events and safety outcomes over 3 years. The main outcome is the rate of a composite of ASCVD events. Secondary outcomes include rates of individual cardiovascular events, death from any cause, hospitalization for heart failure, major bleeding, and safety endpoints. Participants will provide informed consent and follow the study protocol with scheduled clinical follow-ups to assess these outcomes.