Mian Yang Shi

Researchers are evaluating TQB6411 injection, an antibody-conjugated drug that targets EGFR and c-Met proteins on tumor cells, in people with advanced malignant tumors. The study aims to assess how well patients tolerate the treatment, understand how the drug moves through the body, and observe early signs of its effects. This phase I clinical trial focuses on patients who have advanced cancer and have not responded to or cannot tolerate standard treatments. TQB6411 is given by intravenous injection every three weeks, with doses ranging from 0.8 mgkg to 8 mgkg at the start of each treatment cycle. The antibody in TQB6411 binds to cancer cells to block important growth signals, and then releases toxins inside the cells to cause DNA damage and cell death. The study includes a dose escalation stage to find the maximum tolerated dose and a dose expansion stage for specific tumor types such as advanced non-small cell lung cancer and metastatic colon cancer. Participants will have regular blood tests and tumor imaging to monitor safety and treatment effects for up to 24 months. Researchers will track dose-limiting toxicities, adverse events, drug levels in the blood, tumor response rates, and survival outcomes. Women of childbearing potential must use effective contraception during and for six months after the study. The trial includes careful monitoring to assess the bodys reaction to the drug and to gather information for future studies.

Researchers are evaluating the combination of LBL-024 with other drugs for treating patients with advanced non-small cell lung cancer NSCLC in this open-label, multicenter phase II clinical trial. The study aims to assess the efficacy and safety of LBL-024 combined with various chemotherapy drugs. It plans to enroll up to 230 participants who have advanced solid tumors and measurable lesions. The trial consists of four cohorts, each including a safety run-in period where a small group receives LBL-024 combined with different drugs such as docetaxel, bevacizumab, pemetrexed, carboplatin, and paclitaxel through intravenous infusion. After a 21-day safety observation, researchers evaluate tolerability before continuing enrollment and extension treatments. Some cohorts include maintenance treatment phases with LBL-024 alone or combined with other drugs. Participants will undergo treatment and follow-up visits to monitor response and safety. Researchers will assess outcomes including objective response rate, disease control rate, duration of response, drug concentration levels, and immunogenicity. The study involves regular laboratory tests, physical assessments, and evaluation of measurable tumor lesions. Participation lasts through the treatment and a 28-day follow-up after stopping the study drug or before new anti-tumor therapy starts.

Researchers are studying the safety, tolerability, pharmacokinetics, and early effects of TQB3019 capsules in people with advanced malignant tumors. This Phase I clinical trial uses a single-center, open, non-randomized, single-arm design. The study includes two phases dose escalation and dose expansion, aiming to find appropriate dosing and assess initial responses in patients with recurrent or refractory blood cancers who have at least one measurable tumor. Participants take TQB3019 capsules orally once daily on an empty stomach, with doses ranging from 50 to 600 mg per day. Each treatment cycle lasts 28 days. The study includes both single-dose and continuous dosing regimens, with assessments made throughout these cycles to understand the drugs behavior and effects. During the trial, participants undergo regular monitoring for side effects, laboratory tests, and evaluations of tumor response. Researchers measure dose limiting toxicity, maximum tolerated dose, and recommended doses for future studies, along with overall response rates and survival outcomes up to about three years. Pharmacokinetic parameters such as drug concentration over time are monitored closely at multiple time points within each 28-day cycle to understand how the drug is processed by the body.

Researchers are evaluating budoprutug, a humanized monoclonal antibody designed to selectively bind to CD19, in adults aged 18 to 65 years with active, seropositive systemic lupus erythematosus SLE who have not responded adequately to standard treatments. This Phase 1b2a open-label trial aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of budoprutug, focusing on its effect on B cells and immunoglobulin levels. Participants will receive budoprutug as two intravenous infusions administered 14 days apart in ascending dose cohorts. The study includes dose-escalation and dose-expansion phases to evaluate different dose levels. The treatment is given on Day 1 and Day 15, with monitoring continued up to 28 weeks to assess response and safety. Throughout the study, participants will undergo evaluations including clinical laboratory tests and monitoring of vital signs such as blood pressure, heart rate, respiratory rate, and body temperature. Researchers will measure changes in B-cell counts, immunoglobulin levels, and disease activity scores over time. Safety assessments will include tracking adverse events and dose-limiting toxicities. The total study duration extends up to 28 weeks, allowing for thorough observation of budoprutugs effects.

Researchers are evaluating LBL-047, a study drug given as a single subcutaneous injection, to assess its safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical effects in both healthy adults and patients with systemic lupus erythematosus SLE. This Phase I, double-blind, randomized, placebo-controlled trial aims to understand how the drug behaves in the body and its initial effects in people with mild to moderate SLE. The study is divided into two parts. Part A involves healthy adults receiving escalating doses of LBL-047 or placebo through a single subcutaneous injection, with dose increases guided by a Safety Monitoring Committee. Part B enrolls adult patients with mild to moderate SLE, confirmed safe doses from Part A are administered as a single injection. Participants are randomized to either the drug or placebo groups. Participants will be monitored from the first dose until 85 days after injection for treatment-emergent and serious adverse events, drug levels in the body, immune responses, and pharmacodynamic effects. Assessments include laboratory tests and clinical evaluations to track safety and biological activity. The study plans to enroll 76 participants, with possible additions, and involves scheduled visits, laboratory testing, and safety monitoring throughout the observation period.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of LBL-024 in patients with advanced malignant tumors in a phase III clinical study. This study includes patients who have failed previous standard treatments, lack standard treatment options, or are not suitable for such treatments. The trial consists of two parts a phase IIIa dose escalation and pharmacokinetic expansion phase, and a phase IIb pivotal single-arm clinical study. Participants receive LBL-024 injections at the maximum tolerated dose every three weeks. The phase IIIa part focuses on dose escalation, safety, and preliminary efficacy, while the phase IIb part serves as a single-arm registry study to further assess the treatment. The study evaluates the drugs pharmacokinetic characteristics and immune response throughout treatment. During the study, participants are closely monitored for dose-limiting toxicities within three weeks of the first dose and maximum tolerated dose completion. Researchers assess objective response rate, adverse events, immunogenicity, disease control rate, and progression-free survival. Follow-up visits occur up to 30 days after treatment discontinuation or withdrawal. The total study duration extends until December 2026.

Researchers are evaluating the protective effects, safety, and immune response of an 11-valent recombinant human papillomavirus HPV vaccine in Chinese women aged 18 to 45 years. This Phase III clinical trial involves 13,500 women divided into three age groups to assess the vaccines ability to prevent HPV infections and related cervical lesions. Participants are randomized into experimental and placebo groups to compare outcomes. The trial administers three doses of either the HPV vaccine or a placebo via intramuscular injections into the upper arm deltoid muscle, scheduled at 0, 2, and 6 months. The study uses a double-blind design to ensure unbiased results. The vaccine targets multiple HPV types associated with cervical cancer and related conditions. Participants will undergo follow-up visits including gynecological examinations, pregnancy testing, and monitoring for adverse events. Researchers will measure the incidence of cervical intraepithelial neoplasia CIN and HPV-related lesions, as well as antibody responses at multiple time points after vaccination. The trial includes long-term monitoring up to six years to evaluate vaccine safety and effectiveness.

Researchers are evaluating HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are evaluating AK112, a PD-1VEGF bispecific antibody, as a consolidation treatment for patients with limited stage small cell lung cancer who have not shown disease progression after concurrent chemoradiation therapy. This phase III, randomized, double-blind study aims to compare the effectiveness and safety of AK112 against a placebo in this specific patient group. Participants will receive either AK112 or a placebo intravenously every three weeks as consolidation therapy following their initial chemoradiation. The study includes two groups one receiving AK112 at a dose of 20 mgkg every three weeks, and the other receiving a matching placebo on the same schedule. Treatment continues under close monitoring to assess outcomes. Throughout the study, participants will undergo regular assessments including scans and evaluations to monitor progression-free survival and overall survival over approximately six years. Additional outcome measures include response rates and disease control rates assessed by both independent review and investigators, along with safety monitoring for adverse events. This long-term follow-up helps researchers understand how the treatments perform and their impact on patient health.

Researchers are evaluating brenipatide for adults with moderate-to-severe Alcohol Use Disorder AUD to see how it compares to a placebo in effectiveness and safety. This Phase 3, multicenter, randomized, double-blind study is led by Eli Lilly and Company and aims to better understand treatment options for AUD. Participants in this study will be adults aged 18 to 75 years and will remain in the study for about 56 weeks. Participants will receive either brenipatide or a placebo through subcutaneous injections. The study has multiple treatment periods with escalating doses of brenipatide administered under medical supervision. Both the active drug and placebo are given by injection under the skin. The study uses a randomized design to assign participants to one of the study groups to compare outcomes. During the study, participants will be regularly assessed using questionnaires and diaries to track drinking patterns, alcohol cravings, and overall health. Researchers will also monitor changes in alcohol consumption, body weight, and health survey scores. Blood tests will check drug levels and the presence of antibodies against brenipatide. Safety and treatment effects will be observed for up to 56 weeks, with study visits scheduled throughout this period.