Dangjin

Researchers are evaluating petosemtamab compared with investigators choice monotherapy in patients with incurable metastatic or recurrent head and neck squamous cell carcinoma HNSCC who have previously been treated. This phase 3 open-label, randomized controlled study focuses on patients whose disease has progressed after anti-PD-1 and platinum-containing therapies. It aims to assess effectiveness and safety for second- and third-line treatments in this population. Participants will be randomly assigned to receive either petosemtamab or one of several investigators choice monotherapies, including cetuximab, methotrexate, or docetaxel. The treatments are given as part of a controlled multicenter trial. The study includes follow-up periods to evaluate responses and safety outcomes over time. During the study, participants will undergo regular assessments including radiologic evaluations to measure tumor response according to RECIST criteria, physical performance status checks, and laboratory tests to monitor organ function and adverse events. Researchers will track overall survival for up to approximately three years and evaluate other outcomes such as progression-free survival, response rates, quality of life measures, and treatment safety. The total duration of participation is aligned with treatment and outcome measurement timelines as specified.

Researchers are evaluating zipalertinib, an oral drug, for safety, effectiveness, and how it behaves in the body pharmacokinetics in adults with locally advanced or metastatic non-small cell lung cancer NSCLC that has specific mutations in the epidermal growth factor receptor EGFR, including exon 20 insertions and other uncommon mutations. This Phase 2b trial also studies how zipalertinib interacts with other drugs affecting liver enzymes and transporters and aims to find the best dose for treatment. Participants join one of four main groups based on their treatment history and mutation type those previously treated for exon 20 insertion mutations, those who are untreated but not candidates for standard chemotherapy, those with active brain metastases or leptomeningeal disease, and those with other uncommon EGFR mutations without prior systemic therapy. Two additional substudies focus on drug interactions using enzyme and transporter probe cocktails, and dose optimization with participants randomly assigned to two dosing arms. Zipalertinib is taken orally twice daily continuously until disease progression or other reasons to stop. During the study, participants undergo regular evaluations including scans to measure tumor response, brain imaging if applicable, laboratory tests, heart function monitoring, and assessments of side effects. Researchers track how long participants respond to treatment, disease control, survival, and changes in heart electrical activity. Safety and drug concentration in blood are closely monitored. Participants may remain in the study for up to approximately two years to assess these outcomes.

Researchers are evaluating the safety and effectiveness of targeted blood-brain barrier opening using the Exablate Model 4000 Type 2 focused ultrasound system in patients with brain metastases from non-small cell lung cancer NSCLC. This clinical trial compares this approach combined with immune checkpoint inhibitor ICI therapy to standard ICI therapy alone. The study is a randomized, controlled, multi-center pivotal trial conducted in the US, aiming to improve response rates in brain metastases treatment. Participants will receive either the Exablate blood-brain barrier opening alongside planned FDA-approved on-label ICI systemic therapy or ICI therapy alone as the control. The ICI therapy is administered every 3 weeks for 6 cycles according to approved labeling. The Exablate BBB opening is done on the day of ICI infusion targeting the brain metastases. The trial will compare the objective response rate between these groups during a 6-month follow-up period. During the study, participants will undergo regular assessments including MRI scans to evaluate tumor response and monitoring of adverse events up to 6 months. Neuro-oncology brain metastases response assessments will also be done. Researchers will track safety and efficacy outcomes while participants continue their ICI therapy. The total study duration extends up to about 6 months with close follow-up throughout this period.

Researchers are studying the safety, effectiveness, and how the body processes the investigational drug WAL0921 in adults with various glomerular kidney diseases and proteinuria. These include diabetic nephropathy and rare conditions such as primary focal segmental glomerulosclerosis, treatment-resistant minimal change disease, primary immunoglobulin A nephropathy, and primary membranous nephropathy. This is a Phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers to evaluate WAL0921 compared to a placebo. Participants will be randomly assigned to receive either the investigational drug WAL0921 or a placebo through an intravenous infusion every two weeks for a total of seven infusions. The study includes a treatment period followed by a 24-week follow-up after the last infusion to monitor participants. The treatments are given in parallel groups to compare their effects and safety. During the study, participants will undergo regular assessments including monitoring for adverse events from the start through Week 36. Researchers will also measure changes in albuminuria, proteinuria, and kidney function markers such as estimated glomerular filtration rate over 24 weeks. These evaluations help determine how the drug affects kidney disease markers and overall safety. The total participation time includes treatment and follow-up periods lasting several months.

Researchers are evaluating the Force Feedback function of the da Vinci 5 dV5 robotic surgical system to understand its impact on surgical skill learning and safety during robot-assisted radical prostatectomy RARP in patients with localized prostate cancer. This prospective single-center clinical trial involves 60 male patients and aims to provide objective evidence on how tactile feedback may improve surgical precision and reduce tissue injury compared to previous systems lacking this feature. The study randomly assigns the Force Feedback function to be ON or OFF during each surgery, with two surgeons one expert and one trainee each performing 30 RARP cases. The Force Feedback ON mode provides real-time tactile sensations through robotic instruments, allowing surgeons to feel tissue resistance and potentially improve control. The OFF mode relies solely on visual cues. The seminal vesicle dissection step is specifically assessed for traction force and instrument movement. Participants will undergo detailed intraoperative monitoring, including measurement of traction force, instrument path length, and surgical performance metrics like operative time and clutch counts. Safety is closely monitored through recording complications, blood loss, and patient-reported outcomes related to urinary and sexual function. All surgeries are video-recorded and analyzed to assess precision and learning curves, with follow-up continuing up to the studys completion in 2027.

This research aims to compare the symptoms and appetite levels of patients who have undergone minimally-invasive proximal gastrectomy MIPG versus those who have undergone minimally-invasive total gastrectomy MITG for proximal gastric and gastroesophageal junction cancers. The study seeks to determine if MIPG is linked to better postoperative appetite, improved nutritional status, and maintained body weight compared to MITG. It also investigates patient-reported outcomes, safety, and oncological results related to both surgeries. Participants will complete questionnaires within 30 days before surgery and then at 1, 3, 6, and 12 months after surgery. These questionnaires focus on health, appetite, and quality of life and take about 3 to 5 minutes to finish. The study measures fasting ghrelin levels to explore their relationship with appetite and collects data on symptoms using the MD Anderson Symptom Inventory Gastrointestinal Cancer Module MDASI-GI. During the study, patients will be assessed repeatedly through questionnaires to track changes in symptoms and quality of life over a year following surgery. The main outcome is the symptom inventory questionnaire completed three months after surgery. Researchers will also look into factors affecting quality of life after surgery and monitor safety and cancer outcomes. This observational study includes adults aged 18 and older with specific types of gastric cancer and continues until May 2026.