Ganzhou

Researchers are investigating the safety, tolerability, pharmacokinetics, and biological effects of VG2062, a recombinant human IL12/15 dual-regulated oncolytic HSV-1 injection, in adults with advanced malignant solid tumors that have not responded to standard treatments. This open-label Phase I trial focuses on herpes simplex virus (HSV) seropositive patients and aims to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of VG2062, as well as assess dose-limiting toxicities (DLTs) over a 28-day period from treatment start. The study uses a standard 3+3 dose-escalation design with multiple dosing cohorts, including five dose levels of VG2062. Patients will receive the drug injection and be monitored closely during the 28-day DLT observation period. The trial will evaluate safety, tolerability, and pharmacokinetics throughout the dosing period to guide future dosing recommendations. Participants will be monitored for adverse events and serious adverse events for 12 months following treatment. Safety assessments will include clinical evaluations and laboratory tests. The study requires reliable contraception for patients of childbearing potential during the trial and for 90 days after dosing. Overall participation includes initial screening, treatment, and long-term safety follow-up to thoroughly assess VG2062’s effects in this patient population.

Researchers are conducting a prospective, multi-center, non-interventional cohort study across China to investigate Drug-induced Liver Injury (DILI). The study aims to explore the clinical characteristics, responsible drugs or herbs, patient outcomes, and risk factors associated with DILI. An important goal is to identify new serum markers that could help predict the prognosis of this condition. The study also seeks to develop and validate a prognostic model incorporating these novel serum markers to improve patient care in China. Participants will be followed in a nationwide standardized cohort with long-term monitoring to collect detailed prognostic data on DILI. The study does not involve experimental treatments but focuses on observation and data collection to help understand DILI better. No specific interventions are delivered as part of this research. During the study, participants will undergo evaluations to confirm diagnosis and monitor their liver health over time. Researchers will measure primary outcomes including death or liver transplantation within one year and the occurrence of acute liver failure within one year. The study involves ongoing assessments to gather clinical data and validate the prognostic model based on novel serum biomarkers, aiming to enhance future management of DILI.

Researchers are evaluating the safety and effectiveness of eloralintide, a drug given by injection, in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 study includes both a main phase and an extension phase to understand the drug's impact on body weight and overall health in this population. The study aims to compare eloralintide with a placebo to see how well it works in reducing weight. Participants will receive either eloralintide or a placebo, both administered under the skin once a week. The main study phase will last about 75 weeks, during which participants will be regularly monitored. Those participants who have prediabetes will have the option to continue into an extension phase lasting an additional 2 years to further assess long-term effects. During the study, participants will have their body weight measured at the start and throughout the trial, with the primary outcome being the percent change in body weight at week 64 compared to baseline. Researchers will also monitor safety and any side effects. Participants will be asked about their weight history and health conditions, and they must maintain stable body weight before joining. The total involvement time for most participants will be about 75 weeks, with longer follow-up for some.

Researchers are investigating the safety and effectiveness of eloralintide compared to a placebo in adults with persistent obesity or overweight. This includes people with or without type 2 diabetes who are already on stable weekly incretin therapy. The study is a phase 3, randomized, double-blind trial focusing on this specific group to better understand treatment outcomes. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once a week. The study compares these two treatments over the course of the trial. Participants must continue their stable incretin therapy throughout the study period. The study lasts about 80 weeks in total. Researchers will monitor changes in body weight from the start of treatment to week 64 as the main outcome. Participants will have regular assessments to track their health, safety, and treatment effects during this time.

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

Researchers are evaluating the safety and effectiveness of a new oral medicine called vepugratinib compared with a placebo in adults with advanced or metastatic urothelial carcinoma, a type of bladder cancer that has a specific FGFR3 genetic alteration. This Phase 3 study aims to see if vepugratinib combined with two other drugs, enfortumab vedotin (EV) and pembrolizumab, can improve treatment outcomes for people who have not received prior systemic therapy for their cancer. Participants will receive either vepugratinib or placebo taken orally alongside enfortumab vedotin and pembrolizumab, both administered by intravenous infusion. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison between the vepugratinib and placebo groups. Treatment and monitoring will continue for up to approximately 6 years, allowing long-term assessment of safety and treatment effects. During the study, participants will be regularly evaluated for treatment-related side effects, response rates, and how long the cancer remains controlled without progression. Researchers will use established criteria to measure tumor response and will conduct thorough safety monitoring over the entire study period. Participation may last up to six years, during which participants will undergo laboratory tests, imaging, and clinical assessments to track their health and treatment response.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and early effectiveness of XS-04 tablets in adults with relapsed or refractory hematologic cancers, including B-cell lymphoma, acute myeloid leukemia, and myelodysplastic syndrome. This phase 1 trial aims to find the highest dose patients can tolerate and the recommended dose for future studies while also exploring how the drug is processed in the body and its relationship with biomarkers and food intake. Participants receive XS-04 tablets taken orally twice a day in continuous 28-day treatment cycles. The study includes a dose escalation phase for patients with mature B-cell malignancies who have exhausted other treatments, and a dose expansion phase for patients with specific types of B-cell lymphoma and myeloid tumors. The study evaluates the drug's effects over up to 24 months, monitoring for dose-limiting toxicities and determining the maximum tolerated dose or recommended phase 2 dose. Participants will undergo regular assessments including physical exams, laboratory tests, bone marrow biopsies, and imaging to measure tumor lesions. Researchers will monitor side effects, drug levels, and biological markers throughout the study. Safety will be checked at the end of each treatment cycle, and participants are expected to comply with study procedures and follow-up visits to help evaluate XS-04's impact and tolerability.

Researchers are investigating whether Extract of Ginkgo Biloba Leaves Tablets can help improve thinking and memory in people aged 55 years and older who have had an ischemic stroke, which is caused by a blocked blood vessel in the brain. This phase 4 clinical trial is designed to assess both the effectiveness and safety of this treatment when added to the usual care for stroke recovery. Participants must have had a mild stroke confirmed by an MRI scan and show signs of cognitive impairment. The study takes place at multiple hospitals across China. Participants will be randomly assigned to one of two groups: one group will receive Extract of Ginkgo Biloba Leaves Tablets at a dose of 240 mg daily, divided into three doses of two 40 mg tablets each, along with their standard post-stroke care for 52 weeks. The other group will receive only the standard care recommended by the Chinese Stroke Association. The trial is open-label, meaning both the researchers and participants know which treatment is given. Throughout the year-long study, participants will visit the clinic at 4, 26, and 52 weeks after starting treatment for checkups and testing. Researchers will evaluate changes in cognitive function using tests such as the Montreal Cognitive Assessment, Trail Making Test, Symbol Digit Modalities Test, and Verbal Fluency Test. They will also monitor neurological impairment and any new stroke events. Follow-up phone calls will occur at 12 and 38 weeks to support ongoing monitoring and safety assessments.

Researchers are evaluating the safety and effectiveness of brenipatide at different doses compared with a placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study focuses on participants who have a history of asthma requiring controller medication and recent severe asthma exacerbations. The goal is to better understand how brenipatide impacts asthma control over an extended period. Participants will receive either brenipatide or a placebo, both administered by subcutaneous injection. The study includes a 52-week treatment period during which the effects of the drug on asthma exacerbations and symptoms will be monitored. This randomized, double-blind approach helps compare the responses between the treatment and placebo groups. Study involvement lasts about 65 weeks, covering screening, treatment, and follow-up phases. During the study, researchers will assess participants' asthma control using questionnaires and track the annual rate of asthma exacerbations. Safety and treatment responses will be closely monitored throughout the trial to evaluate the drug's impact and participant well-being.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.