Mian Yang Shi

Researchers are evaluating TQB6411 for injection, an antibody-drug conjugate (ADC) designed to treat advanced malignant tumors by targeting EGFR and c-Met on tumor cells. This drug binds to these receptors to block their signaling pathways, delivering toxins that cause DNA damage and cell death. The trial is a Phase I clinical study assessing the tolerance, pharmacokinetics, and preliminary efficacy of TQB6411 in patients with advanced cancers. Participants will receive TQB6411 administered intravenously. The antibody portion targets tumor cells expressing EGFR and c-Met, leading to internalization and toxin release inside the cells. This process aims to damage and kill tumor cells. The study includes dose escalation to determine the maximum tolerated dose and a dose expansion phase for specific tumor types such as advanced non-small cell lung cancer, metastatic colon cancer, esophageal squamous cell carcinoma, and nasopharyngeal carcinoma. During the study, participants will undergo various assessments including monitoring for dose-limiting toxicities, adverse events, and determination of the recommended Phase II dose over up to 24 months. Safety, pharmacokinetics, and tumor response evaluations will be conducted, alongside laboratory tests and tumor tissue analyses. The study requires compliance with contraception guidelines and includes follow-up for treatment effects and safety throughout the treatment period.

Researchers are evaluating the safety and effectiveness of LBL-024 combined with other drugs in treating patients with advanced non-small cell lung cancer (NSCLC), a type of advanced solid tumor. This open-label, multicenter, phase II study includes four different patient groups to assess this combination therapy. The goal is to understand how well these treatments work together and their safety in this patient population. The study involves a safety run-in period for each group, where a small number of patients receive the LBL-024 combination to monitor tolerability over 21 days. Depending on the safety results, some groups will continue treatment with LBL-024 combined with other drugs such as pemetrexed, or LBL-024 alone for maintenance therapy. Patients are randomized into different arms to receive various combinations of intravenous infusions including LBL-024, docetaxel, bevacizumab, pemetrexed disodium, paclitaxel, and carboplatin. Participants will be closely monitored throughout the study for tumor response using established criteria and safety assessments. Researchers will track the objective response rate from the time patients consent through 28 days after stopping the study drug or before starting new anti-tumor treatment. The study will enroll up to 230 subjects aged 18 to 75 years and includes regular evaluations, laboratory tests, and follow-ups to ensure safety and measure treatment effects.

Researchers are evaluating the safety and effectiveness of TQB3909 tablets in patients who have recurrent or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). This phase Ib/II clinical trial focuses on patients diagnosed according to specific criteria and aims to understand how well this treatment works and how safe it is for this population. The study investigates TQB3909, a drug designed to inhibit the B-cell lymphoma-2 (BCL-2) protein. Participants will receive TQB3909 tablets as part of the treatment regimen. The trial includes monitoring for side effects and disease response over time. The study will measure the recommended phase II dose and assess remission rates through evaluations conducted up to 34 months. Participants will be involved in assessments that include monitoring for adverse events, serious adverse events, and abnormal laboratory results. These will be tracked for up to 34 months to evaluate safety and treatment impact. The study also includes imaging tests for measurable lesions and pregnancy testing for women of childbearing potential. Overall, the trial may last up to nearly three years, with ongoing safety and effectiveness evaluations throughout.

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 safety and effectiveness of two antibiotic treatments, omadacycline and moxifloxacin, in Chinese adults with community-acquired bacterial pneumonia (CABP). This Phase 3b study is designed as a bridging trial to confirm whether omadacycline works as well as moxifloxacin in this specific population, building on results from a global CABP trial. Participants will receive either omadacycline or moxifloxacin through intravenous or oral routes. The treatments are given as a course, with details on dosing schedules not specified. The study compares these two drugs directly to assess their clinical efficacy and safety in treating CABP. During the study, participants will be monitored and evaluated for their clinical response at 18 months after therapy. Researchers will assess symptoms, vital signs, and overall health related to pneumonia to determine treatment success. Safety and efficacy data collected throughout the study will help understand how well each drug performs in this patient group.

Researchers are evaluating a Phase I, double-blind, randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single subcutaneous injection of LBL-047 in healthy adults and patients with systemic lupus erythematosus (SLE). The study also aims to preliminarily evaluate the clinical efficacy of LBL-047 in patients with SLE. This trial involves adults aged 18 to 60 years and includes both healthy individuals and those with mild to moderate SLE. The study has two parts: Part A involves healthy adults who are assigned to one of seven dose groups receiving either LBL-047 or placebo via a single subcutaneous injection, with dose escalation guided by a Safety Monitoring Committee. Part B focuses on adult patients with mild to moderate SLE who will receive a single subcutaneous injection of LBL-047 at doses confirmed safe in Part A. A total of approximately 76 participants are expected to enroll, with a possibility of adding 36 more. Participants will be monitored from the first dose until 85 days after injection for treatment-emergent adverse events and serious adverse events. The study includes scheduled visits, laboratory tests, and other procedures to assess safety and response. Researchers will evaluate the participants' health status using clinical and laboratory assessments throughout the study period to understand the drug's effects and safety profile.

Researchers are conducting a phase I/II clinical trial to study LBL-024 in patients with advanced malignant tumors. This trial aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary effectiveness of LBL-024 in patients who have failed standard treatments or for whom no standard treatment is available or applicable. The study includes different phases to explore dose escalation, safety, and efficacy, with a focus on patients with advanced solid tumors. The treatment involves administering LBL-024 by injection every three weeks. The trial is divided into two parts: Part I includes a phase I/IIa dose escalation and pharmacokinetic expansion to evaluate safety and initial efficacy, while Part II is a phase IIb single-arm pivotal study to further assess the treatment in this patient population. Participants will be monitored through various assessments including safety evaluations, pharmacokinetic testing, and measuring tumor response. Key outcomes include determining the maximum tolerated dose, dose-limiting toxicities within three weeks of the first dose, and the objective response rate. Follow-up visits occur 30 days after treatment discontinuation or withdrawal to evaluate ongoing safety and treatment effects. The study requires participants to be adults aged 18 to 80 years with adequate organ function and an expected survival of at least 12 weeks.

Researchers are evaluating the protective effects, safety, and immune response of an 11-valent recombinant human papillomavirus (HPV) vaccine called Hansenulapolymorpha in Chinese women aged 18 to 45 years. This Phase III randomized, blinded, placebo-controlled trial involves 13,500 women divided into three age groups: 18-26, 27-35, and 35-45 years. The study aims to assess the incidence of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) associated with various HPV types after vaccination. Participants receive either the 11-valent HPV vaccine or a placebo through intramuscular injections in the upper arm deltoid muscle. The vaccination schedule includes three doses given at 0, 2, and 6 months. The trial compares the vaccine's effects against placebo across the different age groups, following strict immunization timing. During the study, women attend follow-up visits and provide information through diary cards and contact forms. Researchers monitor safety, immune responses, and HPV-related cervical changes, including CIN2+ occurrences one month after the third dose. The trial also includes pregnancy testing before vaccination and requires effective contraception during the study. Total participation includes vaccination and follow-up over approximately six years to evaluate long-term outcomes.

Researchers are evaluating the safety and effectiveness of HLX22 combined with trastuzumab and chemotherapy as the first treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 2, double-blind, randomized, and multiregional study compares this combination against trastuzumab and chemotherapy with or without pembrolizumab. The study aims to measure how well the treatments work in controlling the disease and improving survival for up to five years. Participants will be randomly assigned to one of two groups. One group receives HLX22 at 15 mg/kg every three weeks along with trastuzumab, chemotherapy (XELOX regimen), and possibly a placebo for pembrolizumab. The other group receives a placebo for HLX22 plus trastuzumab, chemotherapy (XELOX), and possibly pembrolizumab every three weeks. Treatment continues until the disease worsens, unacceptable side effects occur, withdrawal of consent, or other protocol-specified reasons. Throughout the study, participants will undergo regular assessments including tumor scans reviewed by an independent committee to evaluate progression-free survival and overall survival over up to five years. Other evaluations include safety monitoring and organ function tests. The study tracks how long patients live without disease progression and overall survival, aiming to better understand the benefits and risks of HLX22 combined with current standard treatments.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.