Nan Chong Shi

Researchers are evaluating TQB2934, a special antibody designed to treat multiple myeloma, a type of malignant plasma cell tumor. TQB2934 is a double-specific antibody that binds to both the CD3 receptor on T cells and the BCMA antigen on cancerous plasma cells. This binding helps recruit and activate T cells to attack and kill the cancer cells. The study is a Phase 1 clinical trial focusing on the safety and pharmacokinetics of this treatment in adults with multiple myeloma. The treatment involves subcutaneous injections of TQB2934. The antibody works by activating T cells to release substances that kill BCMA-positive target cells. The study monitors participants over time to assess how the drug is processed in the body, including measures like peak drug concentration and elimination half-life within 120 hours after administration. The trial also tracks adverse events for up to 24 months. Participants will undergo various laboratory tests and assessments to meet study requirements and monitor their health throughout the trial. Researchers will evaluate pharmacokinetics, including peak time, drug concentration, and clearance, as well as safety by recording any adverse events. The study includes careful monitoring of participants' condition and treatment responses, with follow-up lasting up to two years to ensure comprehensive safety data collection.

Researchers are evaluating the efficacy and safety of a new antibody-coupled drug called TQB2102 for injection in patients with unresectable locally advanced, recurrent, or metastatic HER2-positive gastroesophageal adenocarcinoma. This Phase II study focuses on how TQB2102 works in combination with Benmelstobart Injection or Penpulimab Injection, with or without chemotherapy, to target HER2 proteins on tumor cells and potentially improve treatment outcomes. The study aims to assess the Objective Response Rate (ORR) over about one year of participation. The treatments being studied include TQB2102 combined with Benmelstobart and chemotherapy or TQB2102 combined with Penpulimab and chemotherapy. TQB2102 is designed to bind more effectively to tumor cell HER2 proteins, while Benmelstobart and Penpulimab are antibodies that may help the immune system target cancer cells. Different dosing regimens of TQB2102 (6 mg or 7.5 mg) are being evaluated, and chemotherapy may be included depending on the treatment group. Participants will be monitored through regular evaluations during the study, which lasts approximately one year. Researchers will measure tumor response and safety outcomes, including lab tests and imaging to confirm measurable lesions according to RECIST 1.1 criteria. The study also involves reviewing previous PD-L1 expression test results or collecting tumor tissue for testing. Safety is closely observed, and participants must meet specific health criteria to join and continue in the trial.

Researchers are evaluating TQB3019 capsules, a targeted protein degrader, for safety, tolerability, pharmacokinetics, and preliminary effectiveness in people with advanced malignant tumors. This Phase I clinical trial uses a single-center, open, non-randomized, single-arm design and includes patients with recurrent or refractory hematological tumors who have measurable disease and good organ function. The trial is divided into two phases: dose escalation and dose expansion. Participants receive TQB3019 capsules orally in either a single-dose or continuous dosing regimen. The study monitors dose limiting toxicity, maximum tolerated dose, recommended Phase II dose, and maximum assessed dose. The trial also tracks adverse events and serious adverse events from the first dose up to 28 days after the last dose or until other anti-tumor treatment begins, with follow-up lasting up to about three years. Participants will undergo multiple evaluations including safety and response assessments during each 28-day treatment cycle. Researchers will monitor laboratory test results and overall response rate from the first dose until disease progression or death. Safety and tolerability are carefully observed over extended periods to understand the drug's effects. The total participation duration can last up to approximately three years depending on treatment and follow-up.

Researchers are evaluating the effectiveness and safety of Jitongning tablets in adults with active axial spondyloarthritis (ax-SpA). The study aims to determine whether Jitongning tablets lead to better improvement compared to a placebo based on the ASAS20 response, a measure of disease activity improvement. It also examines the tablets' impact on other important functions and symptoms in this patient group. Participants will take either Jitongning tablets or a placebo orally, with three tablets taken twice daily for 8 consecutive weeks. The study is randomized, double-blind, and placebo-controlled, focusing on adults aged 18 to 65 years with specific disease activity and traditional Chinese medicine syndrome features. During the trial, participants will undergo examinations and follow-up visits to monitor their progress and safety. Throughout the study, researchers will assess improvements using the ASAS20 measure at 8 weeks and monitor the safety of Jitongning tablets. Participants will be evaluated through clinical visits and laboratory tests, including markers like C-reactive protein and erythrocyte sedimentation rate. The total duration of treatment and observation is 8 weeks, with careful monitoring to ensure participant safety and collect data on treatment effects.

Researchers are evaluating the effectiveness and safety of opevesostat combined with hormone replacement therapy compared to alternative treatments with abiraterone acetate or enzalutamide in people with metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with one next-generation hormonal agent. This Phase 3 study aims to determine whether opevesostat improves radiographic progression-free survival, assessed by independent central review, in participants with or without androgen receptor ligand binding domain mutations. Participants will receive either oral opevesostat along with hormone replacement therapy drugs such as dexamethasone and fludrocortisone acetate, or they will receive alternative oral treatments including abiraterone acetate with prednisone acetate or enzalutamide. Hydrocortisone can be used as a rescue drug if needed. The study is open-label and randomized, comparing these treatment strategies in participants who have progressed after prior hormonal therapy. During the study, participants will undergo assessments including imaging scans to monitor disease progression. Researchers will measure radiographic progression-free survival up to approximately 52 months. Safety and overall survival are also monitored as secondary outcomes. Participants must attend scheduled visits for evaluations, provide tumor tissue samples, and have ongoing monitoring of organ function, hormone levels, and other relevant health parameters throughout the study period.

Researchers are studying AZD1163, a new bispecific antibody, to assess its effectiveness and safety in adults with moderately-to-severely active rheumatoid arthritis (RA) who test positive for anti-citrullinated peptide antibodies (ACPA). This Phase II, randomized, double-blind, placebo-controlled trial involves participants already receiving standard treatments such as conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or tumor necrosis factor inhibitors (TNFi). Participants will be randomly assigned to one of four groups to receive subcutaneous injections of either one of three doses of AZD1163 or a placebo, alongside their standard care, for 24 weeks. Following this treatment period, there will be a 28-week safety follow-up to monitor participants. Throughout the study, researchers will evaluate changes from baseline in disease activity scores using C-reactive protein levels at 12 weeks. Participants will undergo regular assessments including joint counts and laboratory tests to monitor disease status and safety. The total involvement in the study spans over 52 weeks, including treatment and follow-up periods.

Researchers are evaluating the efficacy and safety of a combination budesonide and albuterol metered dose inhaler (MDI) compared with an albuterol sulfate MDI in symptomatic Chinese adults with asthma. This Phase III, randomized, double-blind, multicenter, event-driven study aims to reduce the risk of severe asthma exacerbations in this population. The study will enroll approximately 790 participants who meet specific asthma-related eligibility criteria. The study includes three periods: a screening period of 14 to 28 days, a treatment period lasting at least 24 weeks and up to 52 weeks, and a safety follow-up period occurring about two weeks after the final visit. Participants will be randomly assigned to one of two treatment groups, receiving either the budesonide/albuterol MDI or the albuterol sulfate MDI as needed for asthma symptoms or before exercise, alongside their usual maintenance therapy. Participants will undergo assessments including lung function tests, asthma control questionnaires, and monitoring of severe asthma exacerbations throughout the treatment period. Researchers will track the time to the first severe asthma exacerbation as the primary outcome. Safety will be monitored during the follow-up period, and participants must demonstrate the ability to use the inhaler correctly and comply with study procedures throughout the trial.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). These participants must have a history of COPD for at least one year and have experienced multiple COPD exacerbations despite using inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on those who have had at least two moderate or one severe exacerbation in the prior year while on inhaled triple or dual therapy. Participants will receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and up to 76 weeks. After the treatment period, there will be a 12-week off-treatment safety follow-up to monitor any lasting effects or safety concerns. During the study, researchers will assess the participants' lung function and monitor the annual rate of moderate or severe COPD exacerbations. Participants will undergo screening to confirm eligibility based on lung function tests, eosinophil counts, and symptom scores. Safety will be closely monitored throughout the treatment and follow-up periods to evaluate adverse effects and overall participant health.

Researchers are evaluating the combination of anlotinib hydrochloride capsules and penpulimab injection as adjuvant therapy for patients with hepatocellular carcinoma (HCC) at high risk of recurrence after radical surgery or ablation. This phase 3, randomized, double-blind, placebo-controlled study aims to compare this combination treatment against a placebo to assess its effect on recurrence-free survival (RFS). Participants will receive either anlotinib hydrochloride capsules combined with penpulimab injection or matching placebos. The study focuses on patients who have undergone radical excision or ablation (radio frequency or microwave) within 4 to 12 weeks before randomization and have high risk factors for recurrence. The investigational drugs target multiple pathways: anlotinib hydrochloride as a multitargeted receptor tyrosine kinase inhibitor and penpulimab as an antibody targeting PD-1. Throughout the study, participants will be monitored for recurrence-free survival up to 3 years from baseline. Eligibility assessments ensure participants have no extrahepatic metastasis or vascular invasion and have recovered from surgery or ablation. The study includes careful tracking of disease status and safety, with follow-up visits to evaluate the treatment's impact on preventing cancer recurrence over time.

Researchers are conducting the China Cognition and Aging Study (China COAST), a large national research project in China aiming to better understand dementia and its subtypes, including mild cognitive impairment (MCI), sporadic and familial Alzheimer's disease (AD), vascular dementia (VaD), and other dementias. The study seeks to clarify the epidemiology, genetic factors, disease characteristics, diagnosis, and treatment status of these conditions. It will also explore risk and protective factors, discover new genes related to dementia, study biomarkers, and evaluate the effectiveness of non-pharmacological treatments over an average of two years. The study involves collecting comprehensive data from community and hospital populations, including demographic information, clinical evaluations, neuropsychological tests, imaging, and biological samples such as blood and cerebrospinal fluid. Genetic analyses like exome sequencing and genome-wide association studies will be performed. Participants will undergo regular follow-ups every 2 to 3 years to update prevalence and incidence rates, assess disease progression, and evaluate lifestyle and non-drug interventions. Randomized controlled trials will be conducted to assess non-pharmacological treatments including exercise, diet, cognitive training, and risk factor control. Participants will be assessed using standardized neuropsychological scales and undergo imaging and laboratory tests to monitor cognitive function and disease progression. Researchers will collect data on genetic markers, biomarkers, and clinical symptoms to develop early diagnostic tools and prediction models. The study also includes education efforts to raise awareness about dementia and investigates stigma and discrimination affecting patients and caregivers. Overall participation may extend over several years with detailed evaluations and follow-up assessments.