Nan Tong Shi

Researchers are evaluating the efficacy and safety of a drug called B007 compared to Cyclosporin in treating Primary Membranous Nephropathy, a kidney condition confirmed by biopsy. This study is a multicenter, randomized, controlled, open-label trial in phase II/III, focusing on patients aged 18 to 80 years with certain kidney function levels and proteinuria. Participants will receive either B007 via subcutaneous injections on days 1 and 15 or oral Cyclosporin capsules dosed at 3.5 mg per kg per day. The study includes screening to confirm eligibility, treatment administration, and monitoring for approximately two years to evaluate overall remission rates. Throughout the trial, participants will be monitored with laboratory tests to meet study standards and ensure safety. Researchers will assess kidney function, protein levels in urine, and remission rates over about two years. Safety will be followed closely, including checking for allergies, infections, and adherence to the treatment protocol.

Researchers are evaluating the efficacy and safety of zonisamide as an add-on treatment for children aged 1 to 14 years with focal epilepsy or secondary generalized tonic-clonic seizures that have not been well controlled by one antiepileptic drug. The study focuses on whether zonisamide can reduce the frequency of epileptic seizures and improve cognitive function, while also monitoring for any side effects that may arise from its use. This is an open-label, phase 4 observational study involving 30 participants. Participants will receive oral zonisamide tablets with a dosing schedule starting from 2 mg/kg/day during weeks 1-2, increasing to 4 mg/kg/day in weeks 3-4, and then to 6 mg/kg/day in weeks 5-6. After the initial six weeks, the dose will be adjusted weekly by 1 mg/kg/day according to each patient's condition, maintaining a dose between 4 and 6 mg/kg/day in one or two divided daily doses. For children weighing 50 kg or more, adult dosing will be applied. During the study, participants will be observed at baseline, week 8, and week 20 to evaluate seizure frequency and other primary outcome measures. Safety assessments include physical exams, monitoring of weight and vital signs, and laboratory tests such as liver and kidney function and complete blood counts. Data collected will be analyzed using statistical software to determine treatment effects. The total study duration runs from August 1, 2024, to July 31, 2027, allowing thorough evaluation of zonisamide’s potential as a new treatment option for difficult-to-control epilepsy seizures.

Researchers are conducting a multicenter, non-interventional, descriptive study to collect and evaluate solid tumor samples from patients diagnosed with non-small cell lung cancer (NSCLC), gynecological (GYN) cancers, biliary tract cancer (BTC), and urothelial carcinoma (UC) in China. The study aims to assess the agreement between different HER2 immunohistochemistry (IHC) testing assays and the consistency in interpretation of these tests. It includes about 2100 patients diagnosed between January 2023 and September 2025 from 12 sites. The study has two phases: enrollment and assessment. During enrollment, approximately 2100 patients will have their HER2 status tested locally using the 4B5 assay, with results reviewed by a committee of pathologists. In the assessment phase, 320 patients will be selected based on HER2 expression levels (IHC 0/1+/2+/3+) across the four cancer types. Tissue samples from these patients will be sectioned into at least 15 slides and sent to central labs for testing with multiple assays including Roche 4B5, MXB, Zhongshan, An Biping, Amoy, and HercepTest. Interpretation concordance will be evaluated by 36 trained pathologists reviewing scanned images of slides. Participants will have their archived tumor tissue evaluated, with a focus on assay performance and consistency of test interpretation. The study measures include negative and positive percent agreement of HER2 IHC 3+ results between different assays and HercepTest over about six months. The study also examines inter-observer agreement among pathologists. Tissue suitability, HER2 expression levels, and cancer types are closely monitored throughout the study timeline.

Researchers are evaluating the safety, effectiveness, and how the body processes YL201 in men with metastatic castration-resistant prostate cancer (mCRPC) in this multicenter, open-label Phase II study conducted in China. The study focuses on patients with advanced prostate cancer that continues to progress despite hormone therapy, aiming to better understand YL201's potential in this condition. Participants will receive YL201 through intravenous infusion either once every three weeks on Day 1 or twice every three weeks on Day 1 and Day 8 within each 21-day cycle. This treatment schedule will continue as per the study protocol. The research aims to determine the best dose of YL201 for future studies and monitor how the drug behaves in the body over approximately three years. During the study, patients will be closely monitored through imaging scans and clinical evaluations to assess tumor response and progression-free survival based on established cancer response criteria. Researchers will also evaluate safety and drug levels in the body. Patients will be followed for about 36 months to collect comprehensive data on treatment effects, side effects, and overall outcomes.

Researchers are evaluating the effectiveness and safety of two treatment combinations for elderly patients newly diagnosed with multiple myeloma who are not planning to undergo stem cell transplant initially. The study compares daratumumab, lenalidomide, and dexamethasone (DRd) with a modified regimen of bortezomib, lenalidomide, and dexamethasone (VRd-lite). The main goals are to measure how long patients survive without disease progression and the rate of minimal residual disease negativity. Participants can choose between the two treatment options. Daratumumab is given intravenously weekly for the first 8 weeks, then every two weeks for 16 weeks, and finally every 4 weeks in later cycles. Bortezomib is administered by injection once a week during each 28-day cycle for 8 cycles. Both groups receive lenalidomide orally for 21 days of each cycle and dexamethasone twice a week. After initial treatment, all participants continue lenalidomide maintenance until the disease worsens or side effects become unacceptable. During the study, participants undergo regular evaluations including tests for disease progression and minimal residual disease status at various time points up to approximately 5 to 8 years. Safety is monitored throughout. The study involves ongoing assessments such as laboratory tests and clinical evaluations to track treatment response, side effects, and overall health during and after therapy.

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 the efficacy of Prolia® in improving bone mass density (BMD) in the lumbar spine at 12 months in participants with glucocorticoid-induced osteoporosis in Mainland China. This Phase 4 open-label study focuses on adults aged 18 years and older who are receiving glucocorticoid treatment. The main goal is to assess the change from baseline in lumbar spine BMD percentage after one year of treatment. Participants will receive Prolia® through subcutaneous injections using a pre-filled syringe. The study is single-arm and open-label, meaning all participants receive the study drug without a comparison group. Prolia® administration and evaluation of bone density will be conducted during the study period. Throughout the study, participants will undergo evaluations including bone density scans of the lumbar spine and hip using dual-energy x-ray absorptiometry (DXA). Laboratory tests will monitor organ function such as hematological, coagulation, renal, and hepatic parameters. Safety and efficacy will be regularly assessed, and participants are expected to complete all scheduled visits and procedures over the study duration.

This research investigates the effects of AP301, a new iron-based phosphate binder, in patients with chronic kidney disease who are receiving maintenance dialysis and have high blood phosphate levels. The study aims to find out if AP301 can lower blood phosphate and how it influences serum calcium, calcium times phosphate levels, and parathyroid hormone levels. Researchers also want to understand what side effects or discomfort patients might experience and whether AP301 improves quality of life in Chinese patients. The trial is a Phase 3, randomized, double-blind, multi-regional study comparing AP301 with a low-dose version of the same drug that acts as a placebo-like comparator. Participants will first stop all phosphate-lowering drugs. Then, they will take either AP301 or the low-dose comparator three times daily with meals for 8 weeks. After that, all participants will take AP301 three times daily for 24 weeks. Finally, they will take either AP301 or the comparator for 3 weeks. During the first 32 weeks, the dose of AP301 may be adjusted up or down based on blood phosphate levels and the study doctor's judgment. Additional treatment may be given if phosphate levels become too high or too low. Throughout the study, patients will be monitored for changes in serum phosphate levels, calcium levels, and parathyroid hormone levels. Researchers will also assess side effects and quality of life. The main outcome measured is the change in serum phosphate concentration from the start of the study to the end of week 8. Participation requires patients to be on dialysis for at least 3 months and to meet certain blood phosphate and calcium criteria, and the study will last at least 35 weeks with various assessments.

Researchers are evaluating the effectiveness and safety of BGB-16673 compared to the investigator's choice of treatment (either bendamustine plus rituximab or high-dose methylprednisolone plus rituximab) in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with covalent Bruton tyrosine kinase inhibitors. CLL and SLL are blood cancers that cause enlarged lymph nodes, spleen, or liver and symptoms such as night sweats, weight loss, and fever, leading to a shorter life expectancy. Participants will be randomly assigned to receive either oral BGB-16673 or the investigator's choice of intravenous bendamustine plus rituximab or high-dose methylprednisolone plus rituximab. About 150 participants in Mainland China and Taiwan will take part in this Phase 3, open-label, randomized study. During the study, researchers will measure how long participants live without their disease worsening, known as progression-free survival, over approximately 23 months. Participant health and disease status will be monitored through imaging, laboratory tests, and clinical assessments to evaluate treatment effects and safety.

Researchers are evaluating the safety and effectiveness of bomedemstat (MK-3543) compared with the best available therapy (BAT) in adults with essential thrombocythemia (ET) who have not responded well to or cannot tolerate hydroxyurea. This phase 3 clinical trial aims to determine if bomedemstat provides a better durable clinicohematologic response in these participants. Participants will receive either bomedemstat as an oral capsule or one of the best available therapies, including anagrelide (oral capsule), busulfan (oral tablet), interferon alfa or its pegylated forms (subcutaneous solution), or ruxolitinib (oral tablet). The study involves a randomized, open-label design where treatments are compared directly. Throughout the study, participants will be monitored for their hematologic response up to about 52 weeks. Assessments include platelet and neutrophil counts before starting treatment to ensure eligibility. Safety and efficacy are tracked to evaluate the long-term impact of the treatments on ET.