Gui Yang 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 investigating HMPL-506, an oral drug, in a Phase 1 clinical study for patients with hematological malignancies such as relapsed or refractory acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and multiple myeloma (MM). The study has two phases: dose escalation and dose expansion, aiming to determine the safest and most effective dose. Approximately 60 to 132 patients are expected to participate, including those with specific genetic mutations or rearrangements related to these blood cancers. In the dose escalation phase, patients receive increasing doses of HMPL-506 orally once daily in 28-day cycles to identify the maximum tolerated dose and recommended Phase 2 dose. Initial doses start at 50 mg daily, with potential escalation based on safety and efficacy data. The dose expansion phase enrolls patients into three cohorts based on disease type and genetics, treating them with the recommended dose in 28-day cycles until disease progression, intolerable side effects, or other defined reasons to stop. Participants will undergo regular safety monitoring, including evaluation of dose-limiting toxicities, serious adverse events, and response to treatment. Tumor response is assessed every cycle for the first six cycles and then every two cycles thereafter, with follow-up lasting up to 42 months. Additional assessments include bone marrow biopsies, laboratory tests, and performance status evaluations. The study tracks participants until disease progression, withdrawal, or study completion to evaluate HMPL-506's safety and preliminary effectiveness.

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 conducting a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of TQH2929 injection in patients experiencing acute flare-ups of generalized pustular psoriasis (GPP). The study aims to provide evidence on how well TQH2929, a humanized monoclonal antibody, works in managing this severe skin condition. A total of 36 patients will participate in the trial. Participants will receive either TQH2929 injections or a placebo, with the placebo containing no active substance. The treatment is administered through injection, and all subjects will use either the study drug or placebo during the trial period. This setup allows researchers to compare outcomes between the two groups under controlled conditions. During the study, participants will be closely monitored through visits and procedures to assess treatment effects and safety. Researchers will measure outcomes such as the percentage of patients achieving a pustule score of zero after one week of treatment. Female participants of childbearing age must agree to use contraception during the study and for six months afterward. The trial will also include safety monitoring for infections, immune status, and other health factors over the course of participation.

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are studying the gut microbiome in people with several serious chronic diseases in China, including various cancers, hypertension, epilepsy, and kidney disease. The study aims to better understand the differences and similarities in gut microbiome patterns linked to these diseases and different regions, and how these patterns affect microbiome-based diagnostic tests. This work is important because past research has shown links between microbial imbalances and disease, but variability between studies has made it hard to draw clear conclusions. This observational study will recruit 500 patients diagnosed with each target disease and 500 healthy control participants matched by age and sex. Researchers will collect detailed information about participants' demographics, lifestyle, diet, medications, and health status. Biological samples including feces, saliva, urine, and blood will be collected for analysis. There is no active treatment or intervention; the study focuses on characterizing the microbiome and related health data. Participants will undergo assessments of their medical history and lifestyle, with sample collections to analyze microbiome and biochemical markers. Researchers will measure the baseline microbiome to identify disease-associated signatures. The study requires participants to be aged 18 to 75 and to have lived in the hospital's province for at least three years. Safety monitoring is observational, with no study treatments given. The total participant involvement includes data and sample collection for cross-sectional analysis.

Researchers are investigating the anti-tumor effects of two drugs, ABSK061 and ABSK043, in patients with metastatic or unresectable solid tumors that have specific FGFR2/3 genetic changes. This Phase 2 study aims to evaluate the overall response rate and other outcomes in various cancer types including HER2-negative gastric/gastroesophageal junction cancer, urothelial carcinoma, non-small cell lung cancer, and other solid tumors. The study targets tumors driven by FGFR alterations regardless of tumor subtype. Participants with FGFR mutations or gene fusions will receive oral ABSK061 and ABSK043 capsules. Those with HER2-negative gastric/gastroesophageal junction cancer and FGFR2 amplification or overexpression will also receive chemotherapy with CAPOX in combination with these drugs. Treatment continues until disease progression, intolerable side effects, withdrawal of consent, or investigator decision. The study includes a screening phase, a treatment phase, and a post-treatment follow-up phase lasting until the participant's death, withdrawal, loss to follow-up, or study end, whichever comes first. During the study, participants will be closely monitored through scans, laboratory tests, and evaluations to assess tumor response, tolerability, and safety. The main outcomes measured include dose-limiting toxicities at the end of the first treatment cycle and progression-free survival over up to five years. Researchers will also track overall response rates and adverse events. The total participation duration varies depending on individual response and study timelines.

Researchers are evaluating LBL-034 in a phase I/II clinical trial to assess its safety, tolerability, pharmacokinetics, immunogenicity, and effectiveness in patients with relapsed or refractory multiple myeloma. This multicenter, open-label study involves patients who have previously been treated for this condition and are seeking new therapeutic options. The study is designed with two parts: phase I for dose escalation and expansion to find the recommended dose, followed by phase IIa to evaluate treatment efficacy and further safety. The treatment involves intravenous infusions of LBL-034, given every two weeks at doses determined during the phase I dose-escalation study. Phase IIa will include four cohorts receiving the recommended phase II dose based on safety and pharmacokinetic results from phase I. Patients will receive the study drug according to the planned dosing schedule, and biological samples will be collected for relevant testing throughout the study. Participants will be closely monitored with assessments including safety evaluations, pharmacokinetics, and immune response tests. The primary outcomes measured will include objective response rate, dose-limiting toxicities, and the maximum tolerated dose over defined observation periods. The study requires patients to follow the treatment and visit schedules, and it plans to enroll a total of 342 patients across both phases to gather comprehensive data on the investigational drug's profile.

This study is an open-label phase II clinical study to explore the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent/metastatic Nasopharyngeal Carcinoma (NPC) who failed or are intolerant to second-line therapy. In this study, eligible subjects will be randomized at 1:1:1 ratio, and the patients will be administered with HLX43 at three different doses via intravenous infusion.