Ganzhou

Researchers are evaluating VG2062, a recombinant human IL1215 dual-regulated oncolytic HSV-1 injection, in people with advanced malignant solid tumors that have not responded to standard treatments. This Phase I, open-label study focuses on participants who have been previously exposed to herpes simplex virus HSV. The trial aims to determine the safety, tolerability, and recommended dose of VG2062 for future Phase II studies. The study uses a standard 33 dose-escalation design with multiple dosing groups, where small cohorts of participants receive increasing doses of VG2062 to monitor safety and identify the maximum tolerated dose MTD and recommended Phase II dose RP2D. The dose limiting toxicity DLT period lasts 28 days from the first treatment. Up to 30 HSV-seropositive participants will be enrolled in this single-arm trial. Participants will be closely monitored for adverse events and serious adverse events over 12 months, with key safety evaluations during the first 28 days. Researchers will also assess pharmacokinetics, biological effects, tumor response rates, duration of response, disease control, progression-free survival, overall survival, and antibody levels. The total participation includes treatment, follow-up, and safety assessments lasting up to one year.

Researchers are conducting a prospective, multi-center observational study in China to better understand drug-induced liver injury DILI. The study aims to explore the clinical features, identify the drugs or herbs causing DILI, assess patient outcomes, and discover new serum markers. The goal is to develop and validate a prognostic model incorporating these novel markers to improve prediction of patient prognosis in China. Participants will be grouped into a modeling group to help build a predictive model for DILI outcomes, and a validation group to test the accuracy of this model. The study collects long-term data to establish and verify these prognostic tools. No experimental treatments are given as this is an observational cohort study. During the study, researchers will monitor participants for key outcomes such as death, liver transplantation, and acute liver failure over one year, as well as chronic DILI and recovery over two years. Data will be collected through regular clinical assessments and laboratory tests. This long-term follow-up will help improve understanding of DILI prognosis and validate new serum biomarkers. Participants will be involved over extended periods to ensure comprehensive outcome measurement.

Researchers are studying the effectiveness and safety of eloralintide in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 trial aims to understand how eloralintide affects body weight and related health measures over a long period. The study includes a main phase and an extension phase for those with prediabetes to evaluate ongoing effects. Participants are randomly assigned to receive one of four doses of eloralintide or a placebo, all given by subcutaneous injection once weekly. The main phase lasts about 75 weeks, and participants with prediabetes may continue in an extension phase for an additional two years. This structure allows researchers to assess both short-term and longer-term outcomes. During the study, participants will have regular visits to measure body weight, body fat, waist size, blood pressure, blood markers like triglycerides and insulin, and quality of life questionnaires. Safety and treatment effects are monitored throughout. The main outcome is the percent change in body weight from the start to week 64, with follow-up continuing up to week 191 for some. Overall participation can last up to several years depending on the participants health status.

Researchers are evaluating eloralintide, a drug given once weekly, in adults who have persistent obesity or are overweight, including those with or without type 2 diabetes. The study focuses on people who are already on stable incretin therapy, aiming to compare the effects and safety of eloralintide to a placebo over about 80 weeks. This phase 3 trial is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive one of four different doses of eloralintide or a placebo, all administered by subcutaneous injection. The treatment period involves weekly dosing, continuing through the study duration. The study uses a double-blind design, meaning neither participants nor researchers know who receives the drug or placebo. The main goal is to measure changes in body weight from the start to week 64, along with other health indicators. Throughout the study, participants will undergo various assessments including measurements of waist circumference, blood pressure, fasting glucose, insulin levels, and inflammatory markers. They will also complete questionnaires about their quality of life and eating behaviors. Researchers will monitor medication use and drug levels in the body to understand how eloralintide behaves. The total participation time is about 80 weeks, with safety and efficacy evaluations at regular intervals.

Researchers are evaluating if adding LY3537982 olomorasib to standard anti-cancer drugs improves treatment for participants with untreated advanced non-small cell lung cancer NSCLC that has a specific KRAS G12C gene change. This Phase 3 treatment study includes participants with locally advanced or metastatic NSCLC and aims to compare this combination against standard care. The study is sponsored by Eli Lilly and Company and could last up to 3 years depending on individual response and disease progression. Participants receive LY3537982 orally combined with pembrolizumab given intravenously in 21-day cycles. Some groups also receive chemotherapy drugs pemetrexed and platinum cisplatin or carboplatin intravenously. There are different dose levels and combinations being tested, including placebo groups for comparison. Treatment continues until specific discontinuation criteria are met. Parts of the study are randomized and double-blinded, with some parts non-randomized for safety lead-in. During the study, participants have regular assessments including imaging scans to measure tumor response, blood tests, and questionnaires about symptoms and quality of life. Researchers monitor side effects and survival outcomes. The main measures include progression-free survival and treatment-emergent adverse events over about one year, with overall survival followed for up to three years. Participants are closely followed throughout treatment and after to evaluate the effects and safety of the study medications.

Researchers are evaluating vepugratinib, a new medicine, to see if it is safe and helpful for people with advanced or metastatic urothelial carcinoma, a type of bladder cancer with FGFR3 genetic changes. This Phase 3 study compares vepugratinib combined with enfortumab vedotin and pembrolizumab against a placebo combined with these same drugs. The trial is sponsored by Eli Lilly and Company and aims to assess treatment safety and effectiveness over a long period. Participants receive either vepugratinib or a placebo orally, together with enfortumab vedotin and pembrolizumab given by intravenous infusion. The study uses a double-blind, randomized design with parallel groups to compare these treatments. There is a safety lead-in phase followed by the main treatment phase, and study participation may last up to approximately 6 years. During the trial, participants will have regular assessments including monitoring for treatment-related side effects, tumor response, progression-free survival, overall survival, and quality of life using questionnaires. Researchers will collect blood samples to measure drug levels and evaluate health status at baseline and throughout the study. Safety and effectiveness outcomes will be tracked up to 90 months, with continuous monitoring to ensure participant well-being over the long-term study period.

Researchers are studying XS-04 tablets in patients with relapsed or refractory blood cancers, including B-cell lymphoma, acute myeloid leukemia, and myelodysplastic syndrome. The main goal is to evaluate the safety and tolerability of XS-04, determine the highest dose patients can handle, and find the recommended dose for future studies. The trial also looks at how the body processes the drug and explores early signs of how well the treatment works, including how food affects drug levels and the relationship between drug exposure and biological markers. This is a Phase I, open-label study with a dose escalation phase and a dose expansion phase. In the dose escalation phase, patients receive increasing doses of XS-04 tablets orally twice daily in 28-day cycles, starting with a smaller initial dose to observe drug behavior. Dose levels range from 1 mg up to 160 mg per day, with adjustments allowed based on safety and drug levels. Following this, selected doses will be studied further in the dose expansion phase with specific patient groups. Treatment is continuous throughout each cycle. Participants will attend visits for safety monitoring, laboratory tests, and assessments throughout the study. Researchers will track adverse events, measure drug levels in blood after single and multiple doses, and evaluate treatment impact through biomarker analysis. Bone marrow samples and imaging will be used to assess disease status. Participants will be followed for up to 24 months to monitor side effects and determine the maximum tolerated dose and recommended Phase II dose. The study ensures careful monitoring of health and treatment effects during and after the trial.

Researchers are evaluating whether Extract of Ginkgo Biloba Leaves Tablets can improve memory and thinking skills in people aged 55 and older who have had an ischemic stroke caused by a blocked blood vessel in the brain. This study also looks at the safety of taking these tablets alongside usual post-stroke treatments. Participants must have had a stroke confirmed by MRI within 7 to 14 days before joining the study and have mild cognitive impairment after their stroke. Participants will be randomly assigned to one of two groups one group will take 240 mg of Extract of Ginkgo Biloba Leaves Tablets daily for 12 months in addition to their usual stroke care, while the other group will receive only their usual care without the tablets. The study will take place at hospitals across China and will last for 52 weeks for each participant. Throughout the study, participants will visit the clinic at 4, 26, and 52 weeks after starting treatment for checkups and tests, including brain scans, cognitive assessments such as the Montreal Cognitive Assessment and other neuropsychological tests, and evaluations of neurological function. Follow-up phone calls will occur at 12 and 38 weeks to monitor health and any new stroke events. Researchers will measure changes in thinking, memory, cognitive speed, verbal skills, and neurological status to understand the tablets effects and safety over time.

Researchers are evaluating the safety and effectiveness of brenipatide at different dose levels compared with placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study aims to better understand how brenipatide may affect asthma symptoms and exacerbations over one year of treatment. Participants in this study are adults aged 18 to 75 years with a history of asthma and recent severe exacerbations. Participants will be randomly assigned to receive either one of two doses of brenipatide or a placebo, all administered by subcutaneous injection. The treatment period lasts 52 weeks, during which participants receive their assigned injections and are monitored regularly. The study includes a screening period before treatment and a follow-up period after treatment to assess ongoing safety and effects. During the study, participants will attend visits to complete questionnaires, lung function tests such as forced expiratory volume in one second FEV1, and assessments of asthma control and medication use. Researchers will monitor asthma exacerbation rates, rescue medication use, and the presence of anti-drug antibodies. The total study duration including screening, treatment, and follow-up is approximately 65 weeks.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.