Jin Zhou Shi

Researchers are evaluating the effectiveness and safety of TQB2102 for injection compared to a standard chemotherapy regimen called TCbHP in patients with HER2-positive breast cancer. This phase III, randomized, open-label, multi-center study focuses on neoadjuvant treatment, which is therapy given before surgery. The study aims to measure the total pathological complete response and other outcomes such as event-free survival and overall survival. Participants receive either TQB2102 for injection at 6 mgkg by intravenous infusion every 3 weeks for 8 cycles or a combination of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin given intravenously every 3 weeks for 6 cycles. The study monitors participants throughout the treatment period and collects data on tumor response and side effects. During the study, participants will undergo assessments including tumor response evaluations by independent review and investigators, safety monitoring for adverse events, and laboratory tests. Follow-up will continue for up to 50 months after the start of the study to observe long-term outcomes. Participants are expected to comply with contraceptive use requirements and attend all scheduled visits for treatment and evaluations.

Researchers are evaluating the efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the effectiveness, safety, and tolerability of elecoglipron alone or combined with dapagliflozin compared with a placebo in adults with type 2 diabetes mellitus T2DM who are not adequately controlled by lifestyle management alone or who are on other background glucose-lowering medications. This Phase III study aims to understand how these treatments impact blood sugar control and related health factors. Participants will be randomly assigned to one of four groups elecoglipron at dose level 1 with dapagliflozin-matched placebo, elecoglipron at dose level 2 with dapagliflozin-matched placebo, a combination of elecoglipron at one of the studied doses with dapagliflozin, or matching placebos for both drugs. All treatments are taken orally once daily. The study uses a quadruple-blind design to compare these options over a treatment period lasting up to 40 weeks. During the study, participants will have their blood sugar levels measured by changes in Hemoglobin A1c HbA1c from baseline to week 40. Other assessments include body weight, blood pressure, and the time to start any additional rescue medication. Participants will attend regular visits for monitoring and safety evaluations throughout the study duration, which extends until the primary completion date in July 2028.

Researchers are evaluating the efficacy, safety, and tolerability of combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.

Researchers are evaluating the real-world effectiveness of Repatha combined with standard of care SOC compared to SOC alone in Chinese adults with established atherosclerotic cardiovascular disease ASCVD. The study focuses on the risk of major cardiovascular events such as cardiovascular death, heart attack, stroke, hospitalization for unstable angina, or coronary revascularization. This observational study aims to understand how these treatments work when used according to local clinical practice. Participants are divided into two groups based on treatment decisions made independently of the study enrollment those receiving Repatha with SOC and those receiving SOC alone. The study observes these participants over a period of up to 72 months to assess outcomes. Treatment choices follow local guidelines and approved labels, ensuring minimal impact on routine care. During the study, participants undergo regular monitoring for cardiovascular events and changes in cholesterol levels, including low-density lipoprotein cholesterol LDL-C. Researchers also track adverse events and reactions throughout the follow-up period. Participants remain under usual care, and data collection occurs alongside routine clinical visits, with a total participation time of up to six years.

Researchers are evaluating whether combining tucatinib with trastuzumab and mFOLFOX6 works better than standard treatments for people with HER2 positive colorectal cancer that has spread or cannot be removed by surgery. This Phase 3 study also aims to learn about the side effects that may occur when taking this combination of drugs. Participants have metastatic or unresectable colorectal cancer and are randomly assigned to different treatment groups. Participants are randomly placed in one of two study groups. One group receives tucatinib taken orally twice daily along with trastuzumab given intravenously every 3 weeks and mFOLFOX6 chemotherapy every 2 weeks. The other group receives standard care, which may be mFOLFOX6 alone or combined with bevacizumab or cetuximab, both given intravenously on different schedules. Tissue samples and biopsies are collected before treatment to confirm HER2 positivity and other markers. During the study, participants will have regular evaluations including imaging scans to measure cancer progression, blood tests, and assessments of side effects and quality of life. Progression-free survival is the primary outcome measured for up to about 3 years, with other outcomes like overall survival and response rate also tracked. Safety monitoring continues for about one year after the last treatment. The study lasts several years, with ongoing follow-up to understand long-term effects and benefits.

Researchers are comparing the effects and safety of two drugs, GQ1005 and Trastuzumab Emtansine T-DM1, in adults with HER2-positive breast cancer that cannot be removed by surgery or has spread to other parts of the body. This phase III trial focuses on patients who have previously been treated with trastuzumab and taxane. The study aims to understand which treatment might better manage this advanced form of breast cancer. Participants will be randomly assigned to receive either GQ1005 or T-DM1. Both drugs are given through intravenous infusions every 21 days. About 228 patients will take part, and the treatments will continue to be monitored over approximately 24 months to assess their impact on cancer progression and safety. During the study, participants will have regular assessments including scans to measure tumor size and blood tests to monitor the drugs in their system. Researchers will track how long patients live without cancer progression, overall survival, response rates, adverse events, and quality of life changes. These evaluations will help understand the benefits and risks of each treatment over time.

Researchers are evaluating TST001, a Claudin18.2 monoclonal antibody, in an open-label, multi-center Phase IIIa trial for adults with locally advanced or metastatic solid tumors. The study aims to assess the safety, tolerability, pharmacokinetics, and preliminary effectiveness of TST001 alone and in combination with other therapies in cancers such as gastric, gastroesophageal junction, biliary tract, pancreatic, lung adenocarcinoma, and colorectal cancer. This trial is sponsored by Suzhou Transcenta Therapeutics Co., Ltd. The trial consists of two parts Part I involves dose escalation and expansion of TST001 as a mono-therapy administered intravenously every 2 or 3 weeks using a 33 design to determine the recommended dose. Part II evaluates TST001 in combination with other drugs like Oxaliplatin, Capecitabine, Paclitaxel, Gemcitabine, Cisplatin, and Nivolumab in similar dose escalation and expansion phases. Multiple cohorts target different cancer types and treatment histories, with about 320 to 540 participants expected in total. Participants will receive scheduled intravenous doses of TST001 or combination therapies, and researchers will monitor safety by tracking adverse events, dose-limiting toxicities, and lab tests up to 30 to 90 days after treatment. Pharmacokinetics and immune responses will be measured through blood samples. Tumor response, disease control, progression-free survival, and overall survival will be evaluated. The study includes follow-up for up to 30 days after the last dose and requires participants to meet specific health and lab criteria before enrollment.

Researchers are evaluating the effectiveness of combining anlotinib hydrochloride capsules with penpulimab injection as an additional treatment after radical surgery or ablation for patients with hepatocellular carcinoma HCC who are at high risk of cancer returning. This Phase 3 randomized, double-blind, placebo-controlled study aims to compare this combination therapy to a placebo to assess recurrence-free survival RFS over a period of up to three years. Participants receive either the anlotinib capsules plus penpulimab injection or matching placebos in 21-day treatment cycles. The study groups include an experimental arm receiving both active drugs and a control arm receiving placebo capsules and injections. This approach helps researchers understand how well the combination works in preventing cancer recurrence after initial treatment. Throughout the study, participants will have their health monitored regularly, including assessments of recurrence-free survival, time to cancer recurrence, time to spread outside the liver or vascular invasion, overall survival, and response rate after any recurrence. These evaluations will occur from the start of the study and continue for up to three years to track long-term outcomes and safety.