Qingdao

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 evaluating the effectiveness and safety of a drug called B007 in people with generalized myasthenia gravis, a condition that affects muscle strength. This study is a Phase II/III clinical trial designed to compare B007 with a placebo to better understand its impact on daily living activities in affected patients. Participants receive either a high or low dose of B007 or a matching placebo, both given as subcutaneous injections on days 1 and 15. The study includes two groups: those treated with B007 and those given placebo, with treatment administered twice during the trial period. During the study, participants will be monitored for changes in their myasthenia gravis activities of daily living profile (MG-ADL). The main outcome measured is the proportion of participants whose MG-ADL score decreases by 2 or more after approximately 16 weeks. Safety and adherence are also tracked throughout the study.

Researchers are evaluating the efficacy and safety of a drug called B007 compared to Cyclosporin in treating Primary Membranous Nephropathy, a kidney condition confirmed by biopsy. This study is a multicenter, randomized, controlled, open-label trial in phase II/III, focusing on patients aged 18 to 80 years with certain kidney function levels and proteinuria. Participants will receive either B007 via subcutaneous injections on days 1 and 15 or oral Cyclosporin capsules dosed at 3.5 mg per kg per day. The study includes screening to confirm eligibility, treatment administration, and monitoring for approximately two years to evaluate overall remission rates. Throughout the trial, participants will be monitored with laboratory tests to meet study standards and ensure safety. Researchers will assess kidney function, protein levels in urine, and remission rates over about two years. Safety will be followed closely, including checking for allergies, infections, and adherence to the treatment protocol.

Researchers are evaluating the efficacy and safety of Recombinant Botulinum Toxin Type A (YY001) injection for treating upper limb spasticity in adults with unilateral hemiplegia caused by stroke. This randomized, double-blind, multi-center phase II/III study focuses on adults aged 18 to 75 years who have experienced at least 3 months since stroke onset and exhibit functional impairments in hygiene, dressing, limb position, or pain due to spasticity. Participants will receive a single intramuscular injection of either Recombinant Botulinum Toxin Type A (YY001) at doses between 200 to 400 units, BOTOX® at 200 units, or a placebo prepared with 0.9% Sodium Chloride. The study monitors effects at 4 weeks after treatment, comparing the changes in muscle tone using the Modified Ashworth Scale among the groups. During the study, participants' disability levels, treatment adherence, and any side effects will be assessed. Oral antispasticity medication and physical or occupational therapy, if ongoing, must be stable before enrollment. Safety monitoring includes exclusion of individuals with allergies to study drugs, recent botulinum toxin use, fixed limb contractures, or other medical conditions that increase risk. The study spans screening, treatment, and follow-up to ensure thorough evaluation of outcomes and safety.

Researchers are evaluating TQB3019 capsules, a targeted protein degrader, for safety, tolerability, pharmacokinetics, and preliminary effectiveness in people with advanced malignant tumors. This Phase I clinical trial uses a single-center, open, non-randomized, single-arm design and includes patients with recurrent or refractory hematological tumors who have measurable disease and good organ function. The trial is divided into two phases: dose escalation and dose expansion. Participants receive TQB3019 capsules orally in either a single-dose or continuous dosing regimen. The study monitors dose limiting toxicity, maximum tolerated dose, recommended Phase II dose, and maximum assessed dose. The trial also tracks adverse events and serious adverse events from the first dose up to 28 days after the last dose or until other anti-tumor treatment begins, with follow-up lasting up to about three years. Participants will undergo multiple evaluations including safety and response assessments during each 28-day treatment cycle. Researchers will monitor laboratory test results and overall response rate from the first dose until disease progression or death. Safety and tolerability are carefully observed over extended periods to understand the drug's effects. The total participation duration can last up to approximately three years depending on treatment and follow-up.

Researchers are evaluating a combination treatment using BNT326 and BNT327 in adults with advanced or metastatic non-small cell lung cancer (NSCLC), including those with relapsed, progressive, or treatment-nafve disease. This multi-site, open-label study includes dose-finding and dose-expansion phases to investigate the safety, tolerability, and preliminary effectiveness of this combination therapy. The study targets patients whose tumors are advanced, metastatic, or recurrent with no curative treatment options available and includes participants with different genomic alterations. The study is divided into several parts: Part 1 is a dose escalation phase to find safe dose levels of BNT326 with BNT327; Part 2a expands the dose to further evaluate safety and initial efficacy; Part 2b focuses on dose optimization and understanding the contributions of each component. Participants receive intravenous infusions of BNT326 and BNT327, with some cohorts possibly receiving additional treatments such as pembrolizumab or standard chemotherapy. Treatment continues until disease progression, unacceptable side effects, withdrawal, or a maximum of 24 months. Dose levels for certain cohorts are determined based on earlier phase data, and some parts include randomization to different treatment groups. Participants undergo a screening period before starting treatment, followed by treatment, safety follow-up, efficacy follow-up, and long-term survival monitoring, totaling about 36 months. Researchers assess dose-limiting toxicities within the first 21 days of treatment and monitor adverse events, treatment interruptions, and objective response rates up to 36 months. Tumor measurements, safety labs, imaging, and patient health status are regularly evaluated. The study tracks tolerability and efficacy while ensuring participant safety throughout treatment and follow-up.

Researchers are evaluating the safety, tolerability, how the body processes the drug, and early antitumor effects of BG-C137, an antibody-drug conjugate targeting FGFR2b, alone and combined with other anticancer drugs in people with advanced solid tumors. This study includes two phases: Phase 1a focuses on dose escalation and safety, while Phase 1b involves dose expansion. The trial is sponsored by BeOne Medicines, formerly BeiGene. Participants receive BG-C137 through intravenous infusion. In combination groups, anticancer agents are given either intravenously or orally. Phase 1a includes monotherapy dose escalation, safety expansion, and combination dose confirmation and safety expansion. Phase 1b focuses on dose expansion. The study will determine the maximum tolerated dose, recommended doses for expansion, and overall response rates over approximately two years. During the study, participants will undergo evaluations including safety monitoring for adverse events, pharmacokinetic and pharmacodynamic assessments, and tumor response measurements using RECIST v1.1 criteria. Researchers will collect tumor tissue samples to assess FGFR2b expression and other biomarkers. Participants' physical function, organ health, and prior treatments will be reviewed. The total study duration may last up to about two years, with close monitoring of side effects and treatment effects throughout.

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 evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are conducting a multi-center observational study in China to create a national group of patients diagnosed with hydatidiform mole, a type of molar pregnancy. The study aims to investigate how often these moles become malignant and to understand the mechanisms behind this transformation. The ultimate goal is to develop and promote precise diagnosis and treatment strategies for this condition across China. The study does not involve any interventions or treatments but focuses on careful monitoring and data collection. Patients diagnosed with hydatidiform mole will be followed up after uterine evacuation, with particular attention to their serum hCG levels. Those with partial hydatidiform mole may stop follow-up after hCG levels normalize, while those with complete hydatidiform mole require monthly monitoring for six months due to a higher risk of malignant progression. Participants will undergo regular blood tests to monitor postoperative b-hCG levels every 1 to 2 weeks initially, with ongoing monitoring as needed. Researchers will collect complete clinical and pathological data, and follow patients to observe any malignant changes. The study also involves signing informed consent and ensuring participants have no serious infections, immune system diseases, or psychiatric disorders. The total follow-up includes at least six months after hCG normalization or ongoing monitoring for those who develop postmolar gestational trophoblastic neoplasia.