Gan Zhou Shi

Researchers are evaluating BLU-5937, an oral drug, in adults with refractory chronic cough, including unexplained chronic cough, in a randomized, double-blind, placebo-controlled Phase 3 study. The main goal is to assess how BLU-5937 affects 24-hour cough frequency over 24 weeks. This study also monitors safety by tracking adverse events and changes in various health parameters during the treatment period. Participants are randomly assigned to one of three groups BLU-5937 25 mg twice daily, BLU-5937 50 mg twice daily, or a matching placebo taken twice daily. The treatment lasts for 24 weeks, and participants receive their assigned oral medication regularly throughout this time. The study uses a parallel-arm design and includes an extension in China. During the study, participants undergo assessments including cough frequency measurement, vital signs, blood tests for hormones and chemistry, hematology, and ECGs at baseline and Week 24. Researchers also evaluate cough severity and quality of life using questionnaires. Safety is closely monitored by recording adverse events, treatment discontinuations, and laboratory changes. The total participation duration is 24 weeks, with follow-up assessments at specified intervals.

Researchers are evaluating the safety, effectiveness, and behavior of GT719 Injection, a biological treatment, in adults with relapsed or refractory CD19-positive B-cell non-Hodgkin lymphoma and B-acute lymphoblastic leukemia. This early phase 1 clinical trial includes a dose escalation and an expansion phase. The study will enroll 34 participants to understand how the treatment works in these blood cancers. Participants will receive the GT719 Injection as the study treatment. The trial involves a single treatment group receiving this injection to assess its effects and safety. The study includes monitoring after the infusion, focusing on adverse events, dose tolerance, and the behavior of infused cells over time. During the study, participants will be closely observed for any side effects and treatment responses. Researchers will assess adverse events within 28 days and monitor overall response, duration of response, survival rates, and infused cell activity up to 12 months. Participants will undergo medical exams, lab tests, and imaging as needed to track these outcomes and ensure safety throughout the trial, which runs until December 2027.

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 evaluating TQB2102, an antibody-drug conjugate designed to target Human Epidermal Growth Factor Receptor 2 HER2 in patients with locally advanced or metastatic non-small cell lung cancer who have HER2 gene abnormalities. This Phase 2 study aims to assess the effectiveness and safety of TQB2102, which combines targeted antibody action with a potent drug payload that is normally too toxic for general use. Participants receive TQB2102 through intravenous infusion every three weeks, with each treatment cycle lasting 21 days. Some participants will receive TQB2102 alone, while others will receive TQB2102 combined with Benmelstobart, another intravenous drug targeting programmed death ligand-1 PD-L1. Both treatments are given over multiple cycles to evaluate their effects. During the study, participants will be closely monitored through various assessments including measuring tumor response over up to eight months, tracking survival, and recording any adverse events from the start of treatment until 28 days after the last dose. Researchers will also check for immune responses to the drug at several points during and after treatment. The total participation may last up to 18 months to gather comprehensive safety and effectiveness data.

Researchers are evaluating BB-1705, an antibody-drug conjugate, in patients with locally advanced or metastatic solid tumors that have progressed after standard treatments. This Phase I study has two parts a dose-escalation phase to find the safest and most effective dose, and a cohort expansion phase to further assess safety, how the drug moves through the body, and its early anti-tumor effects. BB-1705 is given as an intravenous infusion every three weeks for up to eight cycles. During the dose-escalation phase, different doses are tested to find the maximum tolerated dose, followed by a cohort expansion phase where selected doses are given to more patients to monitor safety and preliminary effectiveness. The study is open label and non-randomized. Participants will have regular visits for safety checks, blood tests, and tumor assessments using imaging every 6 to 9 weeks for up to two years. Researchers will closely track side effects, drug levels, immune responses, tumor response, and progression-free survival. The total study duration includes treatment cycles and follow-up for adverse events and clinical outcomes.

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 studying DB-1311BNT324 in adults with advanced solid tumors that have progressed after standard treatments or have no standard options available. This Phase 12a trial aims to evaluate the safety, tolerability, and early effectiveness of DB-1311BNT324, including its use alone or combined with new hormone therapies in prostate cancer. The study also investigates drug interactions with lopinavirritonavir and itraconazole. Participants receive intravenous doses of DB-1311BNT324 every three weeks at different dose levels to identify the best tolerated dose and recommended dose for further study. The trial includes various groups with specific tumor types, such as small cell lung cancer, non-small cell lung cancer, esophageal cancer, prostate cancer, melanoma, liver cancer, cervical cancer, ovarian cancer, head and neck cancer, and rare tumors. Some groups receive DB-1311BNT324 alone, while others receive it combined with oral hormone therapies or other drugs. During the study, participants undergo regular safety checks including vital signs, blood tests, heart function tests, and cancer status assessments. Researchers monitor side effects, serious adverse events, and tumor responses up to about one year after treatment. The main goal is to find the maximum tolerated dose and assess the drugs safety and preliminary antitumor activity. Participants health and cancer are closely followed throughout and after treatment.

Researchers are evaluating HLX43, an anti-PD-L1 antibody linked to a potent DNA topoisomerase I inhibitor, in patients with recurrent or metastatic Nasopharyngeal Carcinoma NPC who have not responded to or cannot tolerate second-line therapies. This phase II open-label study aims to find the appropriate dose and assess the safety, tolerability, and effectiveness of HLX43 in this patient group. Participants are randomly assigned to one of three HLX43 dose groups. The drug is given through intravenous infusion every three weeks. Treatment continues as long as patients tolerate it well and the disease remains controlled, stopping only if the disease progresses, intolerable side effects occur, another anti-cancer therapy is started, consent is withdrawn, or death occurs. During the study, patients will undergo regular assessments including tumor evaluations to measure response and progression, safety monitoring for adverse effects, and tissue sample collection for PD-L1 expression analysis. The main outcomes measured are the overall response rate within 24 weeks and progression-free survival up to 12 months. Patients will be followed for safety and survival for up to 18 months after treatment starts.

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.