Wu Hu Shi

Researchers are evaluating the safety and effectiveness of CD70-targeted CAR-T cells in treating patients with CD70-positive advanced or metastatic gynecologic cancers. This Phase 1 study focuses on patients who have not responded to standard treatments and aims to find the best doses and infusion methods for these CAR-T cell therapies. The study has two groups based on how the CAR-T cells are given one group receives the treatment through intravenous infusion, and the other through intraperitoneal injection. Each group undergoes two phases a dose discovery phase that uses a dose-escalating design to find recommended doses, followed by a dose expansion phase to further evaluate safety and effectiveness at those doses. Participants receive doses ranging from 1 to 10 million cells per kilogram. Participants will be closely monitored for adverse events and treatment effects over time. Researchers will assess safety outcomes within the first 28 days after infusion and effectiveness outcomes such as disease control and response rates over three months, with longer-term follow-up up to two years. Various lab tests, imaging scans, and clinical evaluations will be done to track how the CAR-T cells behave and impact the cancer. The total study duration and detailed monitoring are designed to ensure participant safety and collect data on how well the CAR-T cells work.

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 IBI343 in people with locally advanced unresectable or metastatic solid tumors in a Phase IaIb, multicenter, open-label, first-in-human study. The trial aims to assess the safety, tolerability, how the drug moves through the body, and its effectiveness. The study includes participants from China, Australia, and the US and involves various stages to find the best dose and combination therapies. IBI343 is given intravenously and the study is divided into multiple parts. Phase Ia includes dose escalation, dose expansion, and dose optimization for monotherapy, with doses adjusted to balance benefits and risks. Phase Ib includes combination therapy with chemotherapy drugs like FOLFIRINOX or mFOLFOX, given every two to three weeks, with randomized groups to determine the optimal dose and safety. Participants will have regular visits for treatment and monitoring, including physical exams, laboratory tests, and imaging to measure tumor response using RECIST criteria. Safety is closely followed through adverse event tracking up to two years, along with assessments of drug levels in the body and immune response. The study also evaluates how tumor markers relate to treatment response, with total participation lasting up to two years.

Researchers are conducting a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to compare HLX17 and US-sourced Keytruda in patients with resected non-small cell lung cancer, melanoma, or renal cell carcinoma. The study aims to evaluate how similar the pharmacokinetic profiles, efficacy, safety, and immune responses are between these two treatments in this patient population. Participants will receive either HLX17 or US-sourced Keytruda. Those in the HLX17 group will get 200 mg on Day 1 of every 3-week cycle for up to 12 months or until disease recurrence, death, new anti-tumor therapy, unacceptable toxicity, consent withdrawal, or study end. The Keytruda group will receive 200 mg every 3 weeks for 8 cycles 24 weeks, then switch to HLX17 on the same schedule until 12 months or similar conditions occur. During the study, participants will undergo various assessments including pharmacokinetic measurements such as drug concentration over time and at steady state, disease-free survival evaluation for up to 12 months, and monitoring for adverse events and laboratory abnormalities for up to 15 months. Safety follow-up includes vital signs, physical exams, ECGs, and immunogenicity evaluation. The total study duration includes treatment and safety monitoring phases.

Researchers are conducting a phase III clinical study to assess the safety, tolerability, pharmacokinetics, immunogenicity, and effectiveness of LBL-034 in patients with relapsed or refractory multiple myeloma, including plasma cell leukemia. The study includes a dose-escalation phase to find the recommended dose and a dose-expansion phase to evaluate treatment effects. The trial is open-label and involves multiple centers. The treatment involves intravenous infusions of LBL-034 at an initial dose defined as the maximum tolerated dose MTD, given every two weeks. The study has two parts the phase I dose escalation and expansion to assess safety and dosage, followed by phase IIa which evaluates efficacy in four patient cohorts. Biological samples will be collected from all participants for testing. Participants will undergo various assessments including monitoring for objective response rate, dose-limiting toxicities, and maximum tolerated dose during treatment and up to 30 days after stopping the drug. Additional evaluations include drug concentration levels, immunogenicity, minimal residual disease, and duration of response. The total trial duration extends until May 2027, with patients followed closely throughout treatment and after drug withdrawal.

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 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 investigating the use of simple imaging methods compared to standard imaging to select stroke patients with anterior large vessel occlusion for thrombectomy treatment. The goal is to see if using simpler imaging techniques like NCCT and CTA is as effective as using more advanced imaging strategies that include CTP and MRI. This trial tests the hypothesis that simple imaging is not worse than the standard approach when it comes to achieving favorable outcomes after treatment. Participants will be randomly assigned to one of two groups one group will be screened using simple imaging methods NCCT and CTA, while the other group will be screened using standard imaging methods that include NCCT-ASPECTS, CTA, and CTP. Both groups will undergo endovascular treatment based on the imaging selection. The study compares these two imaging strategies to determine their impact on treatment decisions and patient outcomes. During the study, researchers will evaluate patients recovery by assessing favorable outcomes at 90 days after endovascular treatment. They will also monitor for safety concerns such as symptomatic intracranial hemorrhage within 48 hours and mortality at 90 days. Participants must be followed for at least 90 days post-treatment to gather these data. The study aims to provide clear information about the best imaging approach for selecting patients for thrombectomy.

Researchers are evaluating BBT001 in a Phase 1, randomized, triple-blinded, placebo-controlled study involving healthy volunteers and adults with moderate to severe Atopic Dermatitis AD. This study aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and clinical activity of BBT001 compared to placebo. It includes two parts Part A with single ascending doses in healthy volunteers and Part B with multiple ascending doses in patients with AD. In Part A, healthy volunteers receive a single dose of either BBT001 or placebo in sequential ascending dose cohorts. In Part B, patients with moderate to severe AD receive seven repeated doses of either BBT001 or placebo. Each part follows a blinded and randomized design to evaluate the effects of the drug and placebo separately. Participants will be monitored for adverse events, changes in vital signs, blood parameters, physical exams, and electrocardiograms up to 141 days Part A or 169 days Part B after the first dose. Pharmacokinetic parameters and immunogenicity are also assessed during this period. The total study duration for participants includes screening, dosing, and extended follow-up to evaluate safety and clinical activity.

Researchers are evaluating the effectiveness and safety of brenipatide combined with standard care compared to a placebo plus standard care for treating schizophrenia in adults aged 18 to 55. This phase 2 clinical trial aims to better understand how brenipatide works alongside existing treatments in this population. Participants are randomly assigned to receive either brenipatide or placebo, both administered by subcutaneous injection, alongside their usual standard of care medications. The study includes a screening period lasting about one month, followed by a treatment period that can last up to 12 months, and then a follow-up period of approximately two months. During the trial, participants will attend scheduled visits to monitor their health, complete questionnaires, and maintain diaries about their medication use. Researchers will measure changes in body weight, neurocognitive function, schizophrenia symptom severity, and other clinical assessments. Safety is closely monitored throughout, and the total participation time may last up to about 15 months.