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Researchers are evaluating the safety and effectiveness of a drug called B001 injection in patients who have neuromyelitis optica spectrum disorder (NMOSD) and test positive for aquaporin-4 antibodies. This study is a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial designed to compare B001 with a placebo in this patient population. The goal is to assess whether B001 can reduce the time to the first NMOSD attack during the study period. Participants will receive either an intravenous dose of B001 or a matching placebo on Day 1 and Day 15 during the randomized controlled period (RCP). Both treatment groups follow the same dosing schedule to evaluate the effects of B001 compared to placebo over approximately 48 weeks. During the study, participants will be closely monitored through regular assessments to track any NMOSD attacks and overall health. Researchers will measure the time to the first NMOSD attack as the primary outcome. Safety and any side effects of the treatment will also be evaluated throughout the study period. Participants are expected to complete all required tests and follow study procedures as part of their involvement.

Researchers are investigating treatments for women with recurrent endometrial cancer that expresses different levels of the HER2 protein. The study has two groups based on the tumor's HER2 score: Cohort 1 includes patients with HER2 IHC 1+ or 2+ who have previously received immune checkpoint inhibitors and platinum-based chemotherapy, while Cohort 2 includes patients with HER2 IHC 3+. The purpose is to compare the effectiveness and safety of the investigational drug BNT323 (also called DB-1303) against chemotherapy in Cohort 1 and to evaluate BNT323 alone in Cohort 2. The study also looks at how the drug affects the immune system, the body's handling of the drug, quality of life, and potential side effects. Participants in Cohort 1 are randomly assigned to receive either BNT323 via intravenous infusion or a chemotherapy drug chosen by the investigator (doxorubicin, paclitaxel, or docetaxel if paclitaxel is unsuitable). Treatment continues until the cancer progresses, unacceptable side effects occur, or the participant withdraws consent. Those in Cohort 2 receive BNT323 alone until disease progression or other discontinuation criteria are met. The study includes a screening period, a treatment period expected to last about six months, followed by safety monitoring, efficacy follow-up, and long-term survival follow-up lasting up to approximately 53 months. During the study, participants undergo regular assessments including imaging scans to measure tumor response by RECIST criteria, safety monitoring for adverse effects, and evaluations of quality of life. Researchers also study the pharmacokinetics of BNT323 and the immune response. The main outcomes measured are progression-free survival in Cohort 1 and objective response rate in Cohort 2. Safety follow-up ensures ongoing monitoring after treatment to evaluate longer-term effects and participant wellbeing.

Researchers are evaluating TQB6411 for injection, an antibody-drug conjugate (ADC) designed to treat advanced malignant tumors by targeting EGFR and c-Met on tumor cells. This drug binds to these receptors to block their signaling pathways, delivering toxins that cause DNA damage and cell death. The trial is a Phase I clinical study assessing the tolerance, pharmacokinetics, and preliminary efficacy of TQB6411 in patients with advanced cancers. Participants will receive TQB6411 administered intravenously. The antibody portion targets tumor cells expressing EGFR and c-Met, leading to internalization and toxin release inside the cells. This process aims to damage and kill tumor cells. The study includes dose escalation to determine the maximum tolerated dose and a dose expansion phase for specific tumor types such as advanced non-small cell lung cancer, metastatic colon cancer, esophageal squamous cell carcinoma, and nasopharyngeal carcinoma. During the study, participants will undergo various assessments including monitoring for dose-limiting toxicities, adverse events, and determination of the recommended Phase II dose over up to 24 months. Safety, pharmacokinetics, and tumor response evaluations will be conducted, alongside laboratory tests and tumor tissue analyses. The study requires compliance with contraception guidelines and includes follow-up for treatment effects and safety throughout the treatment period.

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 role of gut microbiota dysfunction in Alzheimer's disease (AD) and its connection with brain health. This study focuses on the potential modulatory pathway involving gut-derived short-chain fatty acids (SCFAs) and their interaction with brain networks in people across the AD spectrum, including cognitively normal individuals, those with subjective cognitive decline (SCD), mild cognitive impairment (MCI), and AD dementia. The aim is to better understand how the gut microbiome influences brain function and to develop diagnostic tools for early detection of preclinical AD in SCD patients. The study uses high-throughput targeted metabolomics to measure SCFAs and combines gut microbiome analysis with multi-modal MRI techniques to explore the interactions within the "gut microbiota-SCFAs-brain networks." Participants will be grouped based on cognitive status and followed over five years. Multi-omics features from clinical data, gut microbiome, metabolomics, and neuroimaging will be extracted and used to create a diagnostic model for SCD due to preclinical AD through machine learning methods. Participants will undergo standardized cognitive testing, gut microbiome sampling, metabolomic assessments, and brain imaging over the course of five years. Researchers will track changes in the gut microbiome, SCFAs, and multi-omics biomarkers related to conversion from SCD to cognitive impairment. The study will monitor cognitive status, brain function, and gut health regularly to understand disease progression and improve early diagnosis. Safety and health will be monitored throughout the study period.

Researchers are conducting a Phase 1/2a trial to assess the safety and tolerability of DB-1303/BNT323 in people with advanced solid tumors that express HER2. The study focuses on patients with HER2-positive or HER2-expressing malignant solid tumors that are advanced, unresectable, recurrent, or metastatic, and have not responded to standard treatments or have no available standard treatments. This multicenter, open-label study includes an initial dose-escalation phase followed by a dose expansion phase to explore safety, tolerability, and preliminary efficacy of the treatment.

This research aims to evaluate the efficacy, safety, and immune response to HB0017 injection given in different dosing schedules for treating adults with moderate to severe plaque psoriasis. It is a randomized, double-blind phase 2 trial focused on people aged 18 to 75 who have had chronic plaque psoriasis for at least six months and meet specific severity criteria. The study seeks to explore how well HB0017 works and how safe it is for this patient group. Participants will receive HB0017 injections in one of three dosing regimens: 300 mg every 12 weeks, 300 mg every 8 weeks, or 150 mg every 4 weeks. These different administration schedules will be compared to assess their effects. The study is conducted across multiple centers and maintains blinding to reduce bias. During the study, researchers will monitor participants to see what proportion achieve significant skin improvement by week 12, using measures like the Psoriasis Area Severity Index (PASI 90 response) and Static Physician Global Assessment (sPGA 0/1). Safety and immune responses will also be assessed. Participants will be regularly evaluated to track treatment effects and any adverse events throughout the trial period.

Researchers are evaluating SIM0505, a new drug, in adult participants with advanced solid tumors in an open-label, multicenter Phase 1 study. The study aims to assess the safety, tolerability, how the body processes the drug (pharmacokinetics), and early signs of the drug's activity against tumors. Participants must have advanced solid tumors that have not responded to standard treatments or for which no standard treatment is available, including specific types like ovarian cancer, renal cell carcinoma, uterine serous carcinoma, and non-small cell lung cancer without certain mutations. The study includes two main parts: dose escalation and dose optimization. During dose escalation, different dose levels of SIM0505 are tested every 21 days (one cycle) to find the highest dose patients can tolerate safely. In the dose optimization phase, 2-3 dose levels are explored to determine the best recommended dose and to evaluate the preliminary anti-tumor effects. Each cycle lasts 21 days, and dosing continues based on the study protocol. Participants will be monitored through various assessments including safety evaluations, adverse event tracking, and tumor response measurement using standard criteria. The primary outcomes include identifying dose-limiting toxicities by the end of the first cycle, recording adverse events throughout the dose escalation phase (about 2 years), and measuring tumor response during the dose optimization phase (about 1.5 years). Participants will also provide tumor tissue samples for biomarker testing. Overall, participants may be involved in the study for several years depending on the treatment phase and response.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.