Tong Hua Shi

Researchers are evaluating TQB2102, an antibody-drug conjugate designed to target Human Epidermal Growth Factor Receptor 2 HER2 positive tumor cells, in patients with recurrent or metastatic advanced gynecological tumors. This Phase 2 study aims to assess the safety and effectiveness of TQB2102 in this patient population, addressing the need for new treatments after unsuccessful platinum-based chemotherapy. Participants will receive TQB2102 through intravenous infusion every three weeks, with each treatment cycle lasting 21 days. This investigational drug combines a humanized antibody with a potent drug payload to specifically attack tumor cells. The study includes monitoring for adverse events and anti-drug antibodies during treatment and follow-up. During the trial, participants will undergo regular assessments including tumor measurements to evaluate overall response rate, duration of remission, progression-free survival, overall survival, and disease control rate for up to 12 to 17 months. Safety evaluations will continue until 28 days after the last dose or the start of new cancer therapies. Blood samples for anti-drug antibody testing will be collected at specific treatment cycles and after treatment completion. The total involvement period depends on individual treatment duration and follow-up schedules.

Researchers are evaluating the effectiveness of early treatment with BXOS110 injection in reducing disability for patients who have had an acute ischaemic stroke. This phase 3 clinical trial compares BXOS110 to a placebo to better understand its safety and impact when given within three hours of stroke onset. The study includes adults aged 18 to 85 diagnosed with acute ischaemic stroke, with specific neurological and functional criteria for participation. Participants are randomly assigned to one of two groups one receiving a single intravenous infusion of BXOS110 at a dose of 3.0 mgkg up to 300 mg, and the other receiving a placebo infusion of the same volume and dose schedule. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know which treatment is given. The trial consists of a screening and baseline phase, a treatment phase with immediate administration of the study drug, followed by a follow-up period with evaluations on days 2, 3, 10 or at discharge, day 30, and day 90 after treatment. Throughout the study, participants undergo assessments to measure disability and neurological function, including the modified Rankin Scale mRS, NIH Stroke Scale NIHSS, Barthel Index BI, and EQ-5D quality of life questionnaire. The main outcome measured is the proportion of patients achieving an mRS score of 0 to 2 on day 90, indicating good recovery. Safety and efficacy are monitored closely during follow-up visits and at discharge. The total study duration includes screening, treatment, and a 90-day follow-up period to assess outcomes and safety.

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 oral icotrokinra as a treatment for adults and adolescents with moderately to severely active ulcerative colitis, a chronic inflammatory disease of the large intestine causing ulcers in the colon lining. The study aims to assess how well icotrokinra works, along with its safety and tolerability in this population. This is a Phase 3, randomized, double-blind, placebo-controlled trial with a parallel group design including both adults and adolescents. Adult participants will be randomly assigned to receive either icotrokinra or placebo daily by mouth during a 12-week induction phase. At Week 12, those showing clinical response will enter a maintenance phase where they will continue icotrokinra or placebo daily for 40 weeks. Adults who do not respond will also enter the maintenance phase and receive icotrokinra. Adolescents will receive open-label icotrokinra during induction and then continue on icotrokinra during maintenance regardless of response. After completing the 40-week maintenance phase, eligible participants may join a long-term extension study. Participants will be monitored regularly through clinical assessments at specified time points including Week 12 for induction and Week 40 for maintenance. Outcomes measured include rates of clinical remission, symptom improvement, endoscopic and histologic healing, and quality of life scores. Safety will be evaluated by tracking adverse and serious adverse events throughout the study. The total study duration may extend up to approximately 6 years, ending in 2032, allowing long-term evaluation of icotrokinra in ulcerative colitis management.

Researchers are evaluating how well brenipatide LY3537031 is tolerated, its side effects, and its safety and effectiveness in adults with Irritable Bowel Syndrome-Constipation IBS-C. This Phase 2 study compares brenipatide given under the skin with a placebo to better understand its impact on IBS-C symptoms. The trial is sponsored by Eli Lilly and Company and lasts about 35 weeks. Participants will receive either brenipatide or a placebo, both administered subcutaneously. The study uses a randomized, double-blind, placebo-controlled design with parallel groups. Treatment effects will be measured primarily between weeks 9 and 16, focusing on the weekly composite clinical response. Secondary outcomes include abdominal pain and bowel movement responses during the same period. During the study, participants will be monitored for safety and symptom changes. They will record abdominal pain scores daily and bowel habits using a stool form scale. Researchers will review these data along with other health assessments to evaluate the study drugs effects. The total participation duration is approximately 35 weeks, including screening, treatment, and follow-up periods.

Researchers are evaluating the safety, side effects, and effectiveness of brenipatide LY3537031 in adults with Irritable Bowel Syndrome-Diarrhea IBS-D. The study compares brenipatide administered under the skin with a placebo to understand its impact on this condition. This Phase 2 clinical trial involves participants aged 18 to 75 years. Participants will receive either the study drug brenipatide or a placebo through subcutaneous injections. The study follows a randomized, double-blind design where neither participants nor researchers know which treatment is given. Treatment and placebo administrations occur during the trial, which lasts approximately 35 weeks. During the study, participants will be monitored for how well they tolerate the drug and any side effects. Researchers will collect daily data on abdominal pain and stool consistency using an eDiary, focusing on responses between weeks 9 and 24. The primary measure is the percentage of participants achieving a daily composite response for at least half the days between weeks 9 and 16. Safety and efficacy outcomes are tracked throughout the trial period.

Researchers are studying the effectiveness and safety of lebrikizumab in people aged 12 and older who have chronic rhinosinusitis with nasal polyps and are treated with intranasal corticosteroids. This Phase 3 trial compares different dosing schedules of lebrikizumab with a placebo to find out how well it reduces symptoms such as nasal congestion and polyp size over about 18 months. Participants receive lebrikizumab or placebo as subcutaneous injections while continuing their regular intranasal corticosteroid therapy. Adolescents aged 12 to under 18 weighing at least 40 kg will receive open-label lebrikizumab every 2 or 4 weeks. The study includes two experimental lebrikizumab groups with different dosing intervals and a placebo group, all alongside background intranasal corticosteroids. During the study, participants will have regular assessments including symptom severity scores, nasal polyp size measured by endoscopy, sinus imaging, lung function tests, and questionnaires about nasal symptoms and quality of life. Researchers will monitor changes from baseline to week 24 primarily for nasal congestion and polyp scores. Safety and long-term effects will also be observed throughout the study duration of about 18 months.

Researchers are conducting an open-label phase 1 trial to evaluate the safety, tolerability, and pharmacokinetics of the oral drug ABSK-011 in patients with advanced solid tumors. The study includes an escalation part to determine the recommended dose for expansion and an expansion part focusing on patients with advanced liver cancer HCC who have FGF19 overexpression. The trial also explores preliminary antitumor activity of ABSK-011 in this group. During the escalation phase, participants receive a single dose of ABSK-011 followed by a 1-day break to assess pharmacokinetics before continuing daily or twice-daily dosing in 28-day cycles. Dose increases follow a 33 design except for an accelerated titration cohort. In the expansion phase, patients are treated at the recommended dose determined from escalation. A food effect cohort may also be studied. Participants undergo regular monitoring including physical exams, ECOG performance status, ECGs, echocardiograms, and vital signs throughout the study, lasting about six months on average. The team tracks dose-limiting toxicities, adverse events, and treatment adjustments. Pharmacokinetic measures are collected during the first treatment cycle. Tumor response and disease control are also assessed over the study period. Follow-up includes safety and tolerability evaluations after treatment completion.