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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 VVD-130037, a new investigational drug, in people with advanced solid tumors. This Phase 1 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of VVD-130037 alone and combined with chemotherapy drugs docetaxel or paclitaxel, or with the immunotherapy drug pembrolizumab. The study focuses on participants whose cancers have progressed despite previous standard treatments and includes specific groups such as those with squamous non-small cell lung cancer or head and neck squamous cell carcinoma. The study consists of two parts: a dose escalation phase where participants receive VVD-130037 alone or in combination with docetaxel, paclitaxel, or pembrolizumab to determine safe dosage and observe dose-limiting toxicities. Cycle lengths are 21 days for single agent and docetaxel/pembrolizumab combinations and 28 days for the paclitaxel combination. The dose expansion phase involves further evaluation of safety, adverse events, serious adverse events, and laboratory abnormalities over up to approximately four years. Participants will undergo evaluations including tumor measurements based on RECIST criteria, performance status checks, and organ function tests. Safety is closely monitored during the early dose-limiting toxicity periods and throughout the study. Researchers will collect data on side effects, lab results, and overall clinical status to understand how the treatments affect participants over time. The study includes regular follow-up visits and assessments to ensure participant safety and gather comprehensive treatment information.

Researchers are evaluating the safety and effectiveness of combining immunotherapy with particle beam radiation therapy compared to immunotherapy alone in patients with advanced hepatocellular carcinoma (HCC) that involves major blood vessels. This Phase II study focuses on patients with unresectable or locally advanced HCC showing macrovascular invasion, aiming to improve treatment outcomes in this challenging condition. Participants may receive particle beam radiation therapy, with the dose and schedule determined by their physician based on safety considerations for normal tissues like the liver and bowel. The study compares this combined approach against immunotherapy alone. Treatment plans are personalized to balance effectiveness and safety, especially given the complexity of vascular involvement in HCC. During the study, participants will be closely monitored for progression-free survival for up to about three years. Assessments include imaging to measure tumor response, laboratory tests to check organ function, and evaluations of overall health status. Safety and treatment effects will be regularly reviewed to understand the benefits and risks of adding particle beam radiation to immunotherapy in advanced HCC.

Researchers are evaluating the effectiveness of IMC-001 in adults with metastatic or locally advanced solid tumors that have high tumor mutational burden (TMB-H) of 16 mutations per megabase or higher. This Phase 2 study focuses on patients with tumors confirmed by biopsy and who have at least one measurable tumor lesion. The goal is to understand how well IMC-001 works in this specific group of cancer patients. All participants will receive IMC-001 at a dose of 20 mg/kg every two weeks through an intravenous infusion lasting 60 minutes. Treatment may continue for up to two years, with each cycle lasting 14 days. Imaging scans will be performed every six weeks to monitor the tumor response until disease progression or the start of another cancer treatment. A follow-up visit will take place approximately 28 days after the last dose. Participants will undergo regular assessments including imaging scans to measure tumor response using RECIST 1.1 criteria. Safety and effectiveness will be monitored throughout treatment and follow-up. To be eligible, participants must have adequate blood, liver, and kidney function and meet specified health and reproductive criteria. The study also monitors prior treatments and requires patients to have recovered from previous therapies. Total participation duration depends on treatment response and tolerability, with close observation for up to two years.

Researchers are conducting a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b trial to evaluate the effectiveness, safety, and tolerability of IMVT-1402 in adults with Graves' disease who remain hyperthyroid despite antithyroid drug treatment. The study focuses on participants aged 18 to 75 years who have this diagnosis and are still experiencing hyperthyroidism. Participants will receive either IMVT-1402 or a placebo for 26 weeks. The study includes two dosing regimens of IMVT-1402: Dose 1 administered for 26 weeks and Dose 2 also administered for 26 weeks. The placebo group will receive treatment for the same duration. The treatments are given as drugs, and the study is designed to keep both participants and researchers unaware of which treatment is assigned. During the study, researchers will monitor participants to see how many achieve normal thyroid function (euthyroid) and remain off antithyroid drugs by Week 26. Participants will be assessed regularly to evaluate safety, tolerability, and treatment effects. The involvement includes following the assigned treatment and attending scheduled visits for evaluations. The total participation time corresponds with the 26-week treatment period.

Researchers are evaluating the effects of a medicine called BI 764198 in adults and adolescents aged 12 years and older who have a kidney condition known as focal segmental glomerulosclerosis (FSGS). This Phase 3 study aims to understand whether BI 764198 can improve kidney health in people with primary FSGS or genetic FSGS related to TRPC6 gene variants by comparing changes in urine protein levels over 104 weeks. Participants are randomly assigned to one of two groups: one group takes BI 764198 tablets once daily, and the other group takes placebo tablets that look like the medicine but contain no active drug. All participants continue their usual FSGS treatments during the study, which lasts up to two years. During the study, participants visit the study site approximately every three months. They regularly provide urine samples to monitor kidney function, and doctors check their overall health and note any side effects. The main outcome measured is the change in the 24-hour urine protein-to-creatinine ratio from the start of the study to week 104, helping researchers understand the treatment's impact on kidney disease.

This research aims to assess the effectiveness, safety, and tolerability of NGM120 in adults diagnosed with colorectal cancer who also have cancer cachexia, a condition characterized by significant weight loss. This Phase 2, randomized, double-blind, placebo-controlled, multi-center study focuses on participants with active colorectal cancer and cachexia as defined by specific weight loss criteria. Participants will receive either NGM120 administered subcutaneously every 4 weeks or every 8 weeks, or a placebo given subcutaneously every 4 weeks. The study compares these different dosing schedules of NGM120 to evaluate their impact on cancer cachexia symptoms. During the study, researchers will monitor changes in body weight from the start to Week 12, as well as track any treatment-emergent adverse events over a 44-week period. Participants will undergo regular assessments to evaluate safety and treatment effects throughout the study duration.

Researchers are evaluating the effect of low-dose aspirin (100 mg daily) on preventing gastric cancer in patients who have early-stage gastric cancer or high-grade dysplasia and have undergone endoscopic submucosal dissection. This study focuses specifically on patients with negative Helicobacter pylori status or those who have successfully eradicated H. pylori. The study is a phase 3, multi-center, double-blind, randomized, placebo-controlled trial designed to provide clear evidence on aspirin's role in gastric cancer prevention, as previous studies lacked sufficient sample size or follow-up for cancer outcomes. Participants are randomly assigned to receive either a daily 100 mg aspirin tablet or a daily placebo tablet for 5 years. Both groups will be monitored during this treatment period to compare the incidence of gastric cancer between them. This long-term treatment approach aims to provide definitive data on whether aspirin can help prevent metachronous gastric cancer after endoscopic resection. During the study, participants will undergo regular assessments including clinical evaluations and monitoring for side effects or complications. Researchers will track the development of gastric cancer until the last enrolled patient completes the 5-year medication period. Safety monitoring and adherence checks are included to ensure participant well-being and accurate measurement of outcomes over the entire study duration.

Researchers are evaluating whether zongertinib, an oral medication targeting HER2 mutations, can improve outcomes compared to standard adjuvant treatments in adults with completely removed Stage II to IIIB non-small cell lung cancer (NSCLC) with activating HER2 tyrosine kinase domain mutations. Participants must have had surgery intended to cure the cancer and received standard systemic therapy around the time of surgery, including neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy. This global, open-label Phase 3 study aims to assess if zongertinib can extend the time participants remain free from disease. After surgery and necessary systemic therapy, participants are randomly assigned to one of two groups. One group receives zongertinib orally once daily for up to three years. The other group receives standard care, which may include approved adjuvant immunotherapy drugs such as pembrolizumab, atezolizumab, durvalumab, or nivolumab, or observation depending on local medical practices and patient status. This comparison allows researchers to evaluate zongertinib against current treatment standards. Participants will be monitored regularly to assess disease-free survival over a period of up to eight years and five months. Researchers also evaluate overall survival, safety, tolerability, and patient-reported outcomes throughout the study. Tumor samples are collected to confirm HER2 mutation status, and participants' health and organ function are regularly assessed to ensure safety during the trial.

Researchers are evaluating BOLD-100, a new intravenous drug containing a ruthenium-based molecule, in combination with FOLFOX chemotherapy for advanced gastrointestinal cancers including colorectal, pancreatic, gastric, and cholangiocarcinoma. BOLD-100 has shown potential to reduce cancer cell stress markers and demonstrated low toxicity in earlier studies, making it a candidate for combination with standard chemotherapy. This Phase 1b/2a trial includes dose escalation to find safe levels followed by expanded patient groups to further assess treatment effects. Participants receive either BOLD-100 at two different doses combined with FOLFOX chemotherapy or FOLFOX alone. The study includes an initial dose escalation phase to assess safety, followed by an expansion phase focusing on colorectal cancer patients who have had one prior metastatic treatment and are oxaliplatin naive. Patients in the colorectal cancer arm are randomized to one of three groups: 500 mg/m2 BOLD-100 plus FOLFOX, 625 mg/m2 BOLD-100 plus FOLFOX, or FOLFOX alone. Quality of life and neuropathy questionnaires are completed by participants during the study. During the trial, participants undergo monitoring for side effects, dose-limiting toxicities, physical exams, ECGs, vital signs, laboratory tests, and performance status assessments. The study measures progression-free survival, overall response rate, and overall survival for the colorectal cancer group. Safety is followed approximately two weeks after the last treatment. Participants are expected to be ambulatory with adequate organ function and able to complete the study procedures over its duration.