Yong Zhou Shi

Researchers are evaluating the effectiveness and safety of B001 injection in patients who have neuromyelitis optica spectrum disorder NMOSD and test positive for aquaporin-4 antibodies. This condition involves recurrent attacks affecting the nervous system. The study is a multicenter, randomized, double-blind, placebo-controlled trial conducted in phases II and III to understand how well B001 works and how safe it is for these patients. Participants will receive intravenous doses of either B001 or a placebo on Day 1 and Day 15 during the randomized controlled period. The study includes two groups one receiving B001 injections and the other receiving placebo injections matching B001s schedule. The trial will extend over several years, monitoring patients closely for disease relapse and treatment side effects. During the study, participants will be regularly assessed for the time to their first NMOSD attack, changes in disability status, vision acuity, and opticospinal function. Researchers will also observe the annual relapse rate and document any adverse events. The trial includes safety monitoring for about three years to ensure comprehensive data collection on treatment impact and participant health.

Researchers are evaluating FWD1802, a drug being studied for patients with estrogen receptor-positive ER, human epidermal growth factor receptor 2-negative HER2- advanced breast cancer that cannot be removed by surgery or has spread to other parts of the body. This phase III study aims to find the best dose of FWD1802 and assess its safety, tolerability, and effect on tumors, especially in patients whose cancer has specific ESR1 mutations. The study is multicenter, open-label, and includes patients with locally advanced or metastatic breast cancer. The study has three parts Phase I Part A is a dose-escalation phase where up to 27 patients receive increasing doses of FWD1802 tablets, starting with a single dose followed by daily dosing in 28-day cycles. Phase I Part B is a dose-expansion phase exploring 2 to 4 selected dose levels in up to 10 patients per dose to study pharmacokinetics and confirm the recommended dose for Phase II. Phase II focuses on up to 60 patients with ESR1 mutations receiving one or two dose levels to evaluate FWD1802s anti-tumor efficacy and safety. Treatment may continue up to two years or longer if beneficial and agreed upon. Participants will undergo screening including mutation testing and must meet health criteria to join. During treatment, they will receive FWD1802 daily and have blood tests to monitor mutations and drug effects. The study measures safety, drug levels in the body, tumor response, and patient outcomes over about two years. Follow-up includes monitoring for side effects, response to treatment, and disease progression. The trial is designed to gather detailed information about FWD1802s use in this breast cancer type and mutation status.

Researchers are evaluating the protective effects, safety, and immune response of an 11-valent recombinant human papillomavirus HPV vaccine in Chinese women aged 18 to 45 years. This Phase III clinical trial involves 13,500 women divided into three age groups to assess the vaccines ability to prevent HPV infections and related cervical lesions. Participants are randomized into experimental and placebo groups to compare outcomes. The trial administers three doses of either the HPV vaccine or a placebo via intramuscular injections into the upper arm deltoid muscle, scheduled at 0, 2, and 6 months. The study uses a double-blind design to ensure unbiased results. The vaccine targets multiple HPV types associated with cervical cancer and related conditions. Participants will undergo follow-up visits including gynecological examinations, pregnancy testing, and monitoring for adverse events. Researchers will measure the incidence of cervical intraepithelial neoplasia CIN and HPV-related lesions, as well as antibody responses at multiple time points after vaccination. The trial includes long-term monitoring up to six years to evaluate vaccine safety and effectiveness.

Researchers are evaluating the efficacy and safety of SPH4336 alone or combined with Cadonilimab in patients with advanced solid tumors, including advanced well differentiated or dedifferentiated liposarcoma. This is a randomized, open-label Phase IbIIa clinical trial focused on treatment outcomes for patients who cannot be treated with radical surgery or other local therapies. The study is sponsored by Shanghai Pharmaceuticals Holding Co., Ltd. Participants receive either SPH4336 tablets orally at 400 mg once daily in 28-day cycles, Cadonilimab by intravenous infusion at 6 mgkg every 28 days, or a combination of both. The trial includes a dose expansion phase where measurable lesions are required according to RECIST v1.1. Treatments are administered during the study period, with safety and response monitored throughout. During the study, participants undergo regular assessments including laboratory tests to monitor organ function and adverse events. Researchers measure progression-free survival as the primary outcome over approximately two years. Secondary outcomes include response rates, disease control, overall survival up to eight years, and pharmacokinetic measurements. Participants are monitored for side effects and overall health, with involvement lasting through treatment and follow-up periods.

Researchers are evaluating 9MW1911 in adults aged 40 to 75 who have been diagnosed with Chronic Obstructive Pulmonary Disease COPD for at least one year. This Phase II clinical trial is designed to assess how well 9MW1911 works and how safe it is for treating COPD. The study compares two different doses of 9MW1911 given intravenously with a placebo, and aims to better understand treatment effects on COPD flare-ups and lung function. Participants receive intravenous infusions of either 9MW1911 in one of two dose levels or a placebo every 28 days. Each treatment group includes 120 patients, all receiving stable standard care for COPD. The study lasts for 52 weeks of treatment, followed by safety and immune response monitoring up to 60 weeks. Researchers measure lung function, COPD exacerbations, quality of life, and other health markers during this period. During the study, participants will have regular visits for lung function tests, questionnaires about COPD symptoms and quality of life, blood tests, and safety assessments. These assessments occur at multiple time points, such as weeks 0, 4, 8, 12, 24, 36, and 52. The main outcome is the rate of moderate to severe COPD exacerbations over one year. Additional measures include lung function changes, time to first exacerbation, and biological markers. Safety and tolerability are followed for up to 60 weeks to ensure participant well-being throughout the trial.

Researchers are evaluating ALK201, an investigational drug, in adults with advanced solid tumors to assess its safety, tolerability, how the body processes it, and its potential antitumor effects. This first-in-human, open-label study aims to find the best dose for future research. The study is sponsored by Shanghai Allink Biotherapeutics Co., Ltd. and includes adults aged between 18 and 75 years with measurable tumors and good overall health status. The study has two parts Part A is a dose-escalation phase to determine the maximum tolerated dose and the doses for further study, while Part B is a dose-expansion phase enrolling selected patient groups. ALK201 is given intravenously once every three weeks. The study will monitor participants closely during and after treatment to understand the drugs effects and safety profile. Participants will undergo various evaluations including tumor measurements, laboratory tests, and assessments of organ function and immune response over approximately 36 months. Researchers will also track pharmacokinetics and biomarkers to evaluate treatment impact. Safety and tolerability will be assessed continuously, and participants will be followed to observe preliminary antitumor activity and immunogenicity.

Researchers are comparing the effects and safety of two drugs, GQ1005 and Trastuzumab Emtansine T-DM1, in adults with HER2-positive breast cancer that cannot be removed by surgery or has spread to other parts of the body. This phase III trial focuses on patients who have previously been treated with trastuzumab and taxane. The study aims to understand which treatment might better manage this advanced form of breast cancer. Participants will be randomly assigned to receive either GQ1005 or T-DM1. Both drugs are given through intravenous infusions every 21 days. About 228 patients will take part, and the treatments will continue to be monitored over approximately 24 months to assess their impact on cancer progression and safety. During the study, participants will have regular assessments including scans to measure tumor size and blood tests to monitor the drugs in their system. Researchers will track how long patients live without cancer progression, overall survival, response rates, adverse events, and quality of life changes. These evaluations will help understand the benefits and risks of each treatment over time.

Researchers are studying the use of Tenecteplase TNK combined with Butylphthalide NBP in patients who have experienced mild disabling acute ischemic stroke AIS. This large, randomized, double-blind trial compares the effects of TNK plus NBP versus TNK alone to see if the combination improves neurological function and recovery. Patients eligible for the study are adults aged 18 to 80 years who have had a stroke within 4.5 hours and meet specific neurological severity criteria. Participants are randomly assigned to one of two groups. The combination group receives a single intravenous dose of TNK followed by intravenous NBP twice daily for 7 days, then oral NBP capsules three times daily until Day 14. The control group receives the same TNK dose followed by a matching placebo infusion and capsules on the same schedule. Treatments are administered during hospitalization and continue after discharge if needed. Throughout the 90-day study period, participants undergo assessments including stroke severity scores, functional recovery measured by the Modified Rankin Scale, quality of life surveys, and imaging to evaluate brain tissue salvage. Safety monitoring tracks adverse events like bleeding or vascular complications. The main outcome is the proportion of patients achieving minimal disability by 90 days, with additional evaluations of neurological improvement and stroke recurrence.

Researchers are evaluating a new chemotherapy drug called JSKN003 in people with recurrent or metastatic breast cancer that is HER2-low and cannot be removed by surgery. This phase III clinical trial compares JSKN003 to chemotherapy drugs chosen by doctors in patients who have already tried and not responded to one or two previous chemotherapy treatments. The study aims to assess the safety and effectiveness of JSKN003 in this group of patients. Participants are randomly assigned to one of two groups one group receives JSKN003 alone given by intravenous infusion, while the other group receives one chemotherapy drug selected by their doctor from options like capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin. The choice of the chemotherapy drug for the control group is made before randomization. Treatment schedules follow the study protocol at multiple centers. During the study, participants will have regular assessments including scans to measure tumor progression and other tests to evaluate response and overall survival, monitored for up to about three years after enrollment. Researchers will track progression-free survival as the main outcome, along with overall survival, response rate, and duration of response. Safety and side effects will also be closely monitored throughout the study.

Researchers are evaluating the effectiveness and safety of a combination treatment using camrelizumab, apatinib, and eribulin compared to the physicians choice chemotherapy for women with advanced triple-negative breast cancer TNBC. The study focuses on whether this triple-drug regimen can improve progression-free survival and overall survival. Secondary goals include measuring response rates, disease control, clinical benefits, and quality of life, alongside analyzing biomarkers and tracking side effects. Participants in the experimental group receive camrelizumab intravenously on day 1, apatinib orally once daily, and eribulin intravenously on days 1 and 8, all in repeating 21-day cycles. The control group is treated with chemotherapy selected by their physician. This phase III randomized trial compares these two approaches as later-line treatments for advanced TNBC. During the study, participants will undergo regular assessments including imaging to measure tumor response, monitoring for adverse events, and quality of life surveys. Researchers will track progression-free survival up to 60 months and overall survival up to 120 months. Secondary outcomes such as response rate and disease control are assessed up to 12 to 18 months. Safety is monitored from treatment start until 30 days after the last dose. The total study participation could last several years, with ongoing evaluations to understand the treatment impact.