Dangjin

Researchers are conducting a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab with investigator's choice monotherapy in patients with head and neck squamous cell carcinoma (HNSCC) who have incurable metastatic or recurrent disease. This study focuses on patients with progressive disease after anti-PD-1 therapy and platinum-containing therapy and aims to evaluate the treatments as second- or third-line options. Participants will receive either petosemtamab or one of the investigator's choice monotherapies, including cetuximab, methotrexate, or docetaxel. The study involves treatment administration under controlled conditions with monitoring for efficacy and safety. The goal is to assess the treatments over time with a focus on response rates and overall survival. During the study, participants will undergo regular assessments including radiologic imaging to measure tumor response, and evaluations of overall survival up to approximately three years. The primary outcomes include objective response rate assessed by blinded independent central review and overall survival. Researchers will monitor patient health, side effects, and treatment effectiveness throughout the study duration.

Researchers are evaluating the safety, effectiveness, and how the body processes zipalertinib in adults with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that has specific mutations in the Epidermal Growth Factor Receptor (EGFR) gene, including exon 20 insertions and other uncommon mutations. This Phase 2b study also explores potential drug interactions of zipalertinib with certain enzyme and transporter substrates and aims to find the best dosing plan for the medication. Participants will be enrolled into one of four main groups based on their specific EGFR mutation status and treatment history. These groups include those previously treated with exon 20 insertion agents, those untreated and unsuitable for standard chemotherapy, those with active brain metastases or leptomeningeal disease, and those with other uncommon EGFR mutations without prior systemic therapy. Additionally, separate substudies will assess drug interactions using enzyme and transporter probe cocktails and will test different doses of zipalertinib in randomized groups until treatment discontinuation. Throughout the study, participants will undergo regular assessments including imaging scans, neurological exams, and laboratory tests to monitor disease progression and treatment safety. Researchers will track response rates over up to two years and evaluate brain metastasis stability when applicable. Safety monitoring, including cardiac function and adverse effects, will be ongoing. The study requires tissue samples to confirm mutation status and participants will be followed closely to evaluate the medication's impact and tolerability.

Researchers are evaluating the safety, effectiveness, behavior in the body, and biological effects of WAL0921 in adults with certain glomerular kidney diseases that cause proteinuria. These diseases include diabetic nephropathy, primary focal segmental glomerulosclerosis, treatment-resistant minimal change disease, primary immunoglobulin A nephropathy, and primary membranous nephropathy. This study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial designed to better understand how WAL0921 works and its safety profile in these patients. Participants will be randomly assigned to receive either WAL0921 or a placebo through an intravenous infusion every two weeks for a total of seven infusions. After the treatment period, all participants will be monitored for an additional 24 weeks to observe any long-term effects. The study setup allows comparison between the investigational drug and placebo to assess treatment impact. During the study, participants will be closely monitored for any treatment-related side effects from the start of the study through week 36. Regular assessments will include safety checks and evaluations to track how the drug affects their condition. This monitoring aims to ensure participant safety and to measure important outcomes related to kidney health and proteinuria over the entire study period.

Researchers are evaluating how the new Force Feedback feature of the da Vinci 5 (dV5) robotic surgical system affects skill learning and safety during robot-assisted radical prostatectomy (RARP) in men with localized prostate cancer. This phase 2, single-center study compares surgeries performed with the tactile feedback turned ON versus OFF. The study addresses the limitation of prior robotic systems that lack touch sensation, aiming to reduce tissue injury and improve surgical precision by giving surgeons real-time force information. The study will enroll 60 male patients aged 19 and older diagnosed with localized prostate cancer scheduled for RARP at Samsung Medical Center. Two surgeons, one experienced and one trainee, will each perform 30 surgeries with the Force Feedback function randomly activated or deactivated for each case. The Force Feedback ON mode uses sensors to send real-time resistance information to the surgeon's hands, while the OFF mode relies only on visual cues. Key surgical steps, such as seminal vesicle dissection, will be closely monitored to assess force applied and instrument movement. Participants will undergo standard preoperative evaluations and robotic prostatectomy with detailed intraoperative recording of force and instrument paths. Researchers will measure mean traction force and total instrument path length during surgery as primary outcomes. Secondary outcomes include surgical performance, safety events, postoperative complications, and patient quality of life using questionnaires. Safety monitoring follows institutional guidelines, with all adverse events documented. The study aims to provide objective data on how Force Feedback influences surgeon performance and patient safety in robotic prostate surgery.

Researchers are evaluating symptoms and appetite levels in patients undergoing two types of minimally invasive surgeries for proximal gastric and gastroesophageal junction cancers: minimally invasive proximal gastrectomy (MIPG) and minimally invasive total gastrectomy (MITG). The study aims to understand whether MIPG leads to better postoperative appetite, improved nutritional status, and maintenance of body weight compared to MITG. It also investigates patient-reported outcomes, safety, and oncological results following these surgeries. Participants will complete questionnaires using the MD Anderson Symptom Inventory Gastrointestinal Cancer Module (MDASI-GI) before surgery and at 1, 3, 6, and 12 months after surgery. This will include additional experimental questions to assess quality of life and appetite. Fasting ghrelin levels will be checked to correlate with appetite reports. The study compares these outcomes between patients having MIPG and those having MITG. During the study, participants will be asked to complete symptom and quality of life questionnaires at specified times. Researchers will collect data on nutritional measures, safety, and long-term outcomes up to one year post-surgery. The primary outcome is symptom assessment 3 months after surgery using the MDASI-GI questionnaire. This study includes adults aged 18 and older with non-metastatic gastric or gastroesophageal adenocarcinoma scheduled for curative surgery.