Cang Zhou Shi

Researchers are evaluating the safety and effectiveness of a drug called B001 injection in patients who have neuromyelitis optica spectrum disorder (NMOSD) and test positive for aquaporin-4 antibodies. This study is a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial designed to compare B001 with a placebo in this patient population. The goal is to assess whether B001 can reduce the time to the first NMOSD attack during the study period. Participants will receive either an intravenous dose of B001 or a matching placebo on Day 1 and Day 15 during the randomized controlled period (RCP). Both treatment groups follow the same dosing schedule to evaluate the effects of B001 compared to placebo over approximately 48 weeks. During the study, participants will be closely monitored through regular assessments to track any NMOSD attacks and overall health. Researchers will measure the time to the first NMOSD attack as the primary outcome. Safety and any side effects of the treatment will also be evaluated throughout the study period. Participants are expected to complete all required tests and follow study procedures as part of their involvement.

Researchers are conducting a phase III, randomized, open-label, multicenter clinical trial to evaluate the safety and effectiveness of TQB2102 for injection compared to the chemotherapy regimen TCbHP in the neoadjuvant treatment of patients with HER2-positive breast cancer. The study aims to assess key outcomes including the total physiological complete response (tpCR), breast pathological complete response (bpCR), overall response rate (ORR), event-free survival (EFS), invasive disease-free survival (IDFS), overall survival (OS), and adverse events (AEs). Participants will receive either TQB2102, a HER2 dual-antibody drug conjugate, or the TCbHP chemotherapy combination consisting of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin. Treatment is given before surgery as part of the neoadjuvant approach. The study compares these two treatment regimens to determine their relative effectiveness and safety in this setting. During the study, participants will be monitored for response to treatment and side effects over a period of up to 26 months from the start of the study. Evaluations by an Independent Review Committee will include measuring the rate of total physiological complete response. Additional assessments will track other clinical outcomes and adverse events. Participants must comply with study requirements, including surgery after neoadjuvant therapy if appropriate, and safety will be closely observed throughout the trial.

Researchers are evaluating the safety and effectiveness of combining TQ05105 Tablets and TQB3617 Capsules in patients with intermediate- and high-risk Myelofibrosis. This open, single-arm, multi-center clinical trial is conducted in Phase Ib/II to study this combination treatment in adults with this condition. The goal is to find the best dose and assess how well the treatment works, including measuring spleen size reduction. The study treatment includes TQ05105 Tablets, which inhibit Janus kinase 1 and 2, and TQB3617 Capsules, which inhibit Bromodomain and Extra-Terminal proteins. Participants receive these drugs together, but specific dosing schedules are not detailed in the provided information. The study includes multiple phases to evaluate safety and dose levels for up to two years. Participants will undergo various assessments, including measuring spleen volume changes and determining maximal tolerated doses. The main outcomes include the recommended phase II dose and spleen volume reduction over 24 weeks and up to two years. Safety monitoring and evaluation of symptom scores are also part of the follow-up during the study period, helping researchers understand the treatment impact and tolerability.

Researchers are evaluating the effectiveness and safety of TQB6411 for Injection in adults with advanced lung cancer. This clinical trial is designed as a Phase Ib/II study to determine the recommended Phase II dosage and to observe the objective response rate over a period of up to six months. Participants must have confirmed lung cancer with measurable lesions and meet specific health and laboratory criteria to be eligible. The treatment involves administering TQB6411 for Injection every 21 days as a cycle. The study focuses on monitoring the drug’s safety and how well it works in treating advanced lung cancer. Participants will receive this treatment while being closely observed for any side effects or responses to the therapy. During the study, participants will undergo various assessments including laboratory tests, tumor tissue sampling for immunohistochemical testing, and regular health evaluations. The main outcomes measured are the recommended dosage for Phase II and the cancer's response to treatment over six months. Participants will be monitored for safety and treatment effects throughout the study period, which includes initial treatment and follow-up assessments.

This research aims to evaluate the safety, tolerability, and appropriate dosing of BPI-371153, a PD-L1 inhibitor, in adults with advanced solid tumors or relapsed/refractory lymphoma. The study focuses on patients who have progressed after or cannot tolerate standard therapies, including specific cancers like non-driver mutation NSCLC, hepatocellular carcinoma (HCC), and lymphoma. It is a Phase 1 open-label trial designed to find the maximum tolerated dose and recommend a dose for future studies. Participants will receive BPI-371153 continuously until their disease progresses. The study includes a dose escalation phase for adults aged 18 to 65 years and a dose expansion phase open to adults 18 years and older. Patients must have measurable or evaluable lesions depending on their cancer type, and adequate organ function is required. The trial excludes those who have received prior immune checkpoint inhibitors or certain other therapies recently or have specific health conditions. Throughout approximately 24 months, researchers will monitor adverse events and determine the recommended Phase 2 dose. Patients will undergo evaluations including imaging based on RECIST, mRECIST, or Lugano 2014 criteria as appropriate. Safety, pharmacokinetics, and efficacy will be assessed, with careful monitoring for immune-related side effects. Participation duration depends on disease progression and treatment tolerance.

Researchers are investigating the similarity in pharmacokinetic (PK) profile, effectiveness, safety, and immune response of HLX17 compared to US-sourced Keytruda® in patients who have had surgery for non-small cell lung cancer, melanoma, or renal cell carcinoma. This Phase I, multicenter, randomized, double-blind study aims to compare these two treatments in people with these resected solid tumors to better understand their performance and safety profiles. Participants will receive either HLX17 or US-sourced Keytruda®, each given at a dose of 200 mg on the first day of every 3-week cycle. The study is designed with parallel groups, where each participant receives one of the treatments across multiple cycles. The dosing schedule continues through six cycles, and the two treatments are directly compared under controlled conditions. Throughout the study, participants will be monitored closely with various assessments including laboratory tests and evaluations of organ function to ensure safety. The main outcomes measured are drug exposure over time from the first dose to 21 days after the initial and sixth doses. Participants are expected to have a performance status of 0 and a life expectancy of at least 12 weeks. Safety and immunogenicity will also be evaluated, with follow-up to monitor any side effects or immune responses during and after treatment.

Researchers are evaluating the real-world effectiveness of Repatha® combined with standard of care (SOC) compared to SOC alone in reducing major cardiovascular events. The study focuses on people with established atherosclerotic cardiovascular disease (ASCVD) who are treated according to local clinical practice. The goal is to see how these treatments affect the risk of cardiovascular death, heart attacks, stroke, hospitalization for unstable angina, or coronary revascularization. Participants will either be prescribed Repatha® in addition to their existing SOC treatment or continue with SOC alone. The study follows these participants over time to observe outcomes. Treatments are given according to local guidelines and approved labels, reflecting real-world medical care. During the study, researchers will monitor participants for the time until the first occurrence of any major cardiovascular event listed above, for up to 72 months. Participants will undergo regular assessments to track their health status and treatment effects. Safety and effectiveness are observed through ongoing real-world data collection in this prospective, observational study.

Researchers are evaluating AL2846, a multi-target tyrosine kinase inhibitor, in adults with locally advanced or metastatic differentiated thyroid cancer that does not respond to radioactive iodine treatment and has progressed after prior VEGFR-targeted therapy. This phase III clinical trial aims to see if AL2846 can significantly extend the time patients live without disease progression compared to a placebo. The study focuses on patients aged 18 to under 75 years with confirmed disease progression and measurable tumors. Participants will be randomly assigned to receive either AL2846 capsules or a placebo. AL2846 works by targeting multiple receptors involved in cancer growth, including c-MET, c-KIT, VEGFR1, and RET. The study monitors treatment effects over 34 months, assessing progression-free survival. The trial is double-blinded and conducted at multiple centers to ensure reliable comparison of the drug versus placebo. During the study, participants will undergo regular evaluations including tumor measurements per RECIST 1.1 criteria, laboratory tests to monitor blood counts and organ function, and assessments of thyroid stimulating hormone levels. Safety will be closely monitored, and participants must comply with contraception requirements if of childbearing potential. The study duration and follow-up are designed to thoroughly assess how long patients remain free from disease progression while receiving the study treatment or placebo.

Researchers are evaluating the effects of felzartamab in adults with Immunoglobulin A nephropathy (IgAN), a kidney disease caused by the buildup of abnormal IgA antibodies in the kidneys. This buildup leads to inflammation and damage, causing protein to appear in the urine. The study aims to understand how felzartamab influences proteinuria and kidney function, while also assessing the safety and how the body processes this treatment. This is a Phase 3, randomized, double-blind, placebo-controlled study focusing on adults with IgAN. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous (IV) infusions. Neither the participants nor the researchers will know which treatment is given. The treatment period lasts 24 weeks followed by an 80-week follow-up period. In total, participants will attend 17 study visits over about 2 years to receive infusions and participate in study activities. During the study, participants will undergo assessments including urine tests to measure protein levels, kidney function evaluations, and safety monitoring. Researchers will track changes in proteinuria from the start of the study to Week 36 as the main outcome. Additional measurements will include kidney function, clinical endpoints, and the study of how felzartamab is processed by the body. Participant safety and long-term effects will be monitored throughout the study and follow-up periods.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.