Hai Kou Shi

This study is a multicenter, open-label, phase I/II study of YL205 in China to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of YL205 in the following selected patients with advanced solid tumors.

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 conducting a multi-center observational study in China to create a national group of patients diagnosed with hydatidiform mole, a type of molar pregnancy. The study aims to investigate how often these moles become malignant and to understand the mechanisms behind this transformation. The ultimate goal is to develop and promote precise diagnosis and treatment strategies for this condition across China. The study does not involve any interventions or treatments but focuses on careful monitoring and data collection. Patients diagnosed with hydatidiform mole will be followed up after uterine evacuation, with particular attention to their serum hCG levels. Those with partial hydatidiform mole may stop follow-up after hCG levels normalize, while those with complete hydatidiform mole require monthly monitoring for six months due to a higher risk of malignant progression. Participants will undergo regular blood tests to monitor postoperative b-hCG levels every 1 to 2 weeks initially, with ongoing monitoring as needed. Researchers will collect complete clinical and pathological data, and follow patients to observe any malignant changes. The study also involves signing informed consent and ensuring participants have no serious infections, immune system diseases, or psychiatric disorders. The total follow-up includes at least six months after hCG normalization or ongoing monitoring for those who develop postmolar gestational trophoblastic neoplasia.

This research aims to verify the accuracy, stability, and clinical usefulness of artificial intelligence (AI) algorithms for measuring heart function through echocardiography. The study involves collaboration with multiple medical centers and focuses on comparing AI measurements with those done manually by physicians of different experience levels. It also explores whether AI can reduce the time needed for echocardiogram analysis and improve clinical workflows, while assessing AI's performance in complex heart conditions such as cardiomyopathy and valve disease. The study collects echocardiographic data using Mindray ultrasonic machines, with AI and physicians at each center measuring key heart parameters including left and right ventricular size and function. AI and intermediate doctors complete measurements within one day of data collection, while senior physicians at the main research unit finalize their assessments within one month. The goal is to establish a standardized reference system for AI in ultrasound measurement and promote its use across various medical institutions. Participants aged 18 to 80 years with specific heart conditions or normal hearts are involved. Researchers measure heart chamber sizes and functions through echocardiography, comparing AI and physician results for consistency and accuracy. The study also monitors how AI-assisted measurements could optimize diagnosis time and medical resource use. The total duration of participant involvement depends on data collection and measurement timelines, with ongoing analysis to support AI's clinical application in cardiovascular care.

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 safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of an experimental drug called 9MW3011 in adults with non-transfusion-dependent beta-thalassemia. This phase Ib study involves patients aged 18 to 65 who have a genetic diagnosis of beta-thalassemia or hemoglobin E/beta-thalassemia, with a specific range of baseline hemoglobin and evidence of iron overload. The study aims to better understand how this drug behaves in the body and its potential effects in this patient population. A total of 40 participants will be divided into four groups receiving different ascending intravenous doses of 9MW3011 or placebo in a 4:1 ratio. Each group will receive multiple doses according to the study protocol. The study is randomized, double-blind, and placebo-controlled to ensure unbiased assessment of the drug's effects compared to placebo. Participants will be closely monitored up to day 169 for adverse events, changes in vital signs, physical examinations, 12-lead electrocardiogram (ECG) parameters, and laboratory test results. The study includes detailed evaluations of safety and tolerability along with laboratory and clinical assessments to track any significant changes. The total participation duration covers screening, treatment, and follow-up periods to gather comprehensive safety and pharmacological data.

Researchers are evaluating the safety, effectiveness, and how the body processes YL201 combined with serplulimab, with or without platinum-based chemotherapy, in adults with advanced solid tumors such as nasopharyngeal carcinoma (NPC), small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), and others. This phase 1, open-label study is conducted in China and is designed to find the best tolerable dose and assess treatment benefits in this patient group. The study has two parts: Part 1 focuses on gradually increasing doses of YL201 combined with serplulimab (at 4.5 mg/kg every three weeks), with or without platinum chemotherapy (70 mg/m2 every three weeks), to evaluate safety and determine the maximum tolerated dose or recommended dose. Part 2 expands on this by assessing the treatment’s effectiveness using the optimal dose found in Part 1. Treatment schedules occur every three weeks. Participants will undergo evaluations including tumor measurements using RECIST v1.1 criteria, providing tumor tissue samples, and regular checks of organ and bone marrow function. Researchers will monitor side effects, measure tumor response rates, and study how the drugs behave in the body over roughly 36 months. Participants must be able to follow study visits and procedures and have an expected survival of at least 3 months. Safety follow-up and efficacy assessments are included throughout the study duration.

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.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.