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, including ovarian and cervical cancers. This Phase I, single-center, open-label study aims to find the recommended doses and infusion methods for these CAR-T cells. The study includes participants who have not responded to or cannot tolerate standard treatments and have measurable tumors. The study has two treatment groups: one receives CAR-T cells through intravenous infusion, and the other receives them via intraperitoneal injection. Each group undergoes two phases: a dose discovery phase using a dose-escalation design to find the suitable doses, followed by a dose expansion phase to confirm safety and effectiveness of the selected doses. Lymphodepletion with Fludarabine and Cyclophosphamide is given before CAR-T cell administration. Participants will be closely monitored for safety and adverse events for 28 days after infusion. Researchers will assess the maximum tolerated dose of CAR-T cells and observe treatment effects. The study involves various evaluations including physical exams, laboratory tests, and imaging to measure tumor response and overall health. Participants must agree to contraception use and provide informed consent to join the trial.

Researchers are conducting a phase III, randomized, open-label, multicenter clinical trial to evaluate the safety and effectiveness of TQB2102 for injection compared to the chemotherapy regimen TCbHP in the neoadjuvant treatment of patients with HER2-positive breast cancer. The study aims to assess key outcomes including the total physiological complete response (tpCR), breast pathological complete response (bpCR), overall response rate (ORR), event-free survival (EFS), invasive disease-free survival (IDFS), overall survival (OS), and adverse events (AEs). Participants will receive either TQB2102, a HER2 dual-antibody drug conjugate, or the TCbHP chemotherapy combination consisting of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin. Treatment is given before surgery as part of the neoadjuvant approach. The study compares these two treatment regimens to determine their relative effectiveness and safety in this setting. During the study, participants will be monitored for response to treatment and side effects over a period of up to 26 months from the start of the study. Evaluations by an Independent Review Committee will include measuring the rate of total physiological complete response. Additional assessments will track other clinical outcomes and adverse events. Participants must comply with study requirements, including surgery after neoadjuvant therapy if appropriate, and safety will be closely observed throughout the trial.

Researchers are evaluating IBI343, a new investigational drug, in a Phase Ia/Ib, multicenter, open-label study involving participants with locally advanced unresectable or metastatic solid tumors. The study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of IBI343. Participants include those with various solid tumors who have failed or are intolerant to standard therapies, and the study is conducted across multiple countries including China, Australia, and the US. The study includes several parts, including dose escalation, dose expansion, dose optimization, and combination therapy cohorts. IBI343 is administered intravenously every 21 days or every 14 days depending on the study part. Combination therapies with chemotherapy regimens such as FOLFIRINOX/mFOLFIRINOX and mFOLFOX are included in certain cohorts. The study has an initial safety lead-in phase to confirm tolerability, followed by randomized dose optimization stages to determine the recommended Phase 3 dose. Treatments are given in cycles, with specific dosing schedules for each drug involved. Participants will undergo regular assessments including physical exams, vital sign monitoring, laboratory tests, and imaging to measure tumor response based on RECIST criteria. Researchers will track adverse events, dose-limiting toxicities, and treatment-emergent side effects up to 90 days after the last administration, with some outcome measures followed for up to 2 years. The study focuses on determining the objective response rate and safety profile of IBI343 while monitoring participant health and treatment effects throughout the study duration.

Researchers are investigating the similarity in pharmacokinetic (PK) profile, effectiveness, safety, and immune response of HLX17 compared to US-sourced Keytruda® in patients who have had surgery for non-small cell lung cancer, melanoma, or renal cell carcinoma. This Phase I, multicenter, randomized, double-blind study aims to compare these two treatments in people with these resected solid tumors to better understand their performance and safety profiles. Participants will receive either HLX17 or US-sourced Keytruda®, each given at a dose of 200 mg on the first day of every 3-week cycle. The study is designed with parallel groups, where each participant receives one of the treatments across multiple cycles. The dosing schedule continues through six cycles, and the two treatments are directly compared under controlled conditions. Throughout the study, participants will be monitored closely with various assessments including laboratory tests and evaluations of organ function to ensure safety. The main outcomes measured are drug exposure over time from the first dose to 21 days after the initial and sixth doses. Participants are expected to have a performance status of 0 and a life expectancy of at least 12 weeks. Safety and immunogenicity will also be evaluated, with follow-up to monitor any side effects or immune responses during and after treatment.

Researchers are evaluating LBL-034 in a phase I/II clinical trial to assess its safety, tolerability, pharmacokinetics, immunogenicity, and effectiveness in patients with relapsed or refractory multiple myeloma. This multicenter, open-label study involves patients who have previously been treated for this condition and are seeking new therapeutic options. The study is designed with two parts: phase I for dose escalation and expansion to find the recommended dose, followed by phase IIa to evaluate treatment efficacy and further safety. The treatment involves intravenous infusions of LBL-034, given every two weeks at doses determined during the phase I dose-escalation study. Phase IIa will include four cohorts receiving the recommended phase II dose based on safety and pharmacokinetic results from phase I. Patients will receive the study drug according to the planned dosing schedule, and biological samples will be collected for relevant testing throughout the study. Participants will be closely monitored with assessments including safety evaluations, pharmacokinetics, and immune response tests. The primary outcomes measured will include objective response rate, dose-limiting toxicities, and the maximum tolerated dose over defined observation periods. The study requires patients to follow the treatment and visit schedules, and it plans to enroll a total of 342 patients across both phases to gather comprehensive data on the investigational drug's profile.

Researchers are evaluating the safety and effectiveness of MC2-01 cream in treating Chinese adults aged 18 years and older with plaque psoriasis affecting the body (trunk and/or limbs). This phase 3, multi-center, randomized, investigator-blinded study compares MC2-01 cream to both calcipotriol and betamethasone dipropionate gel and a vehicle cream. The study includes screening, treatment, and safety follow-up periods to thoroughly assess the treatment's impact. Participants receive one of three treatments: MC2-01 cream (containing calcipotriene and betamethasone dipropionate), CAL/BDP gel (calcipotriol and betamethasone dipropionate gel), or a vehicle cream without active ingredients. Treatments are applied during the treatment period following the study protocol. The design allows comparison of MC2-01 cream’s efficacy and safety against the gel and vehicle. During the study, participants undergo evaluations including physician assessments using the Physician's Global Assessment (PGA) to measure treatment success on the body after 8 weeks. Researchers monitor safety and treatment response through scheduled visits covering screening, treatment, and follow-up phases. Participation involves completing visits as required by the protocol to ensure comprehensive data collection over the study duration.

Researchers are studying stroke patients with large vessel blockage in the brain to see if a simpler imaging method can effectively select patients for a procedure called thrombectomy. This trial compares the usual detailed imaging approach using CT perfusion or MRI with a simpler method using only NCCT and CTA scans. The goal is to find out if this simpler imaging is as good as the standard method in helping patients achieve favorable outcomes after treatment. Participants will be randomly assigned to one of two groups. One group will be screened using the simplified imaging strategy involving NCCT and CTA scans, while the other group will undergo the standard screening that includes NCCT-ASPECTS, CTA, and CT perfusion imaging. Both approaches are used to decide eligibility for endovascular treatment to remove the blood clot. The study includes patients arriving within 24 hours of stroke onset and uses imaging to guide treatment decisions. During the study, patients will be assessed for clinical outcomes 90 days after the thrombectomy procedure to determine treatment success. Researchers will monitor stroke severity, functional recovery, and safety. Follow-up evaluations will ensure data on patient progress and any complications are collected. Participation involves initial imaging screening, treatment if eligible, and follow-up visits lasting at least 90 days post-treatment to measure results and recovery.

The trial investigates BBT001 in healthy volunteers and adults with moderate to severe atopic dermatitis in a Phase 1 randomized, blinded, placebo-controlled study. It aims to evaluate safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and clinical activity in these two groups. The study includes participants aged 18 to 65 years with specific health criteria and disease severity for atopic dermatitis patients. The study has two parts: Part A administers a single ascending dose of BBT001 or placebo to healthy volunteers in sequential dose groups. Part B involves giving seven repeated ascending doses of BBT001 or placebo to patients with moderate to severe atopic dermatitis. Both parts include placebo control and careful dosing schedules to assess effects over time. Participants will be monitored for adverse events, changes in vital signs, blood tests, physical exams, and ECG results up to day 141 for Part A and day 169 for Part B after the first dose. The study includes assessments of skin condition, pruritus severity, and overall safety. The total study duration and follow-up periods are structured to evaluate safety and clinical outcomes comprehensively.

Researchers are evaluating the safety and effectiveness of brenipatide combined with standard care compared to a placebo with standard care in adults with schizophrenia. This phase 2 study aims to understand how well brenipatide works as an additional treatment for schizophrenia and monitor any side effects. Participants eligible for the study must have schizophrenia and be on stable standard care medication. The trial consists of three main periods: a screening period lasting about one month, a treatment period that can last up to 12 months, and a follow-up period of approximately two months. During the treatment phase, participants receive either brenipatide or placebo administered by subcutaneous injection alongside their standard care. The study includes careful monitoring and adherence to study procedures such as self-injection, keeping diaries, and completing questionnaires. Participants will be involved in regular visits and assessments throughout the entire study duration, which may last up to 15 months. Researchers will measure changes in body weight from baseline to week 52 as a primary outcome. Participants will also be monitored for safety and efficacy through ongoing evaluations, including the use of electronic or paper diaries and required questionnaires to track their progress and response to treatment.

Researchers are evaluating the effectiveness and safety of brenipatide compared to a placebo in adults with Alcohol Use Disorder (AUD) and hazardous alcohol use. This Phase 3, multicenter, randomized, double-blind study aims to understand if brenipatide can help participants reduce or stop drinking. The study lasts approximately 56 weeks and focuses on changes in drinking patterns using the Timeline Followback Method (TLFB). Participants will receive either brenipatide (LY3537031) or a placebo, both administered by subcutaneous injection. Participants who cannot self-inject will have assistance from a trained support person. They are expected to store and use the blinded study drug as directed, maintain electronic and paper diaries, and complete questionnaires throughout the study. During the study, participants will have scheduled visits to monitor their progress, including assessments of drinking behavior and safety evaluations. Researchers will measure changes in alcohol use patterns up to 56 weeks. Participants must be motivated to reduce or stop drinking and be available for all study visits and procedures. Safety and adherence will be closely monitored throughout the trial.