Taizhou

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 combination of BNT324, a B7-H3 antibody-drug conjugate, with BNT327, a bispecific antibody targeting PD-L1 and VEGF, in participants with advanced, metastatic, or relapsed small cell lung cancer SCLC and non-small cell lung cancer NSCLC. This multi-part study aims to find safe doses, optimize treatment, assess preliminary effects, and confirm clinical efficacy in different lung cancer groups. The study includes participants with confirmed lung cancer who have measurable disease and meet specific health criteria. Participants will receive intravenous infusions of BNT324 combined with BNT327 in a dose escalation design to establish two recommended dose levels RP2D and RP2D-1. The study has two parts Part 1 focuses on dose finding in NSCLC and SCLC Part 2 compares these doses in treatment-naive and relapsed lung cancer cohorts, with some randomized groups. Additional participants may join at the optimal dose to further evaluate safety and effectiveness. Participants will undergo screening, followed by treatment, safety follow-up, and long-term survival monitoring. Researchers will assess dose-limiting toxicities, adverse events, treatment interruptions, and response rates using standardized criteria. Outcomes include objective response rate, disease control, progression-free survival, duration of response, and overall survival, with evaluations continuing up to 87 months. Safety is closely monitored during and after treatment, and participants health status is regularly assessed.

Researchers are conducting a large-scale, multicenter, prospective study to understand ischemic stroke better. The study focuses on collecting various biological samples like blood, feces, and urine from patients diagnosed with ischemic stroke to identify biomarkers linked to the condition. By combining demographic data, clinical indicators, imaging results, and biomarker information, the team aims to create models for risk assessment, early warning, and predicting patient outcomes. The study also seeks to identify key genes and explore related signaling pathways associated with ischemic stroke. Participants receive standard care, which may include intravenous thrombolysis with alteplase administered within the appropriate time window after stroke onset. The study groups include patients categorized based on prognosis as those with favorable or unfavorable outcomes. This observational study tracks patients over time without assigning specific treatments beyond usual care. Participants will undergo regular follow-up assessments, including monitoring cerebrovascular events and evaluating modified Rankin Scale scores three months after stroke onset. Various biological samples are collected to support biomarker analysis. The study involves ongoing data collection on clinical, imaging, and biological parameters to support the development of predictive models. The total duration and specific visit schedules vary by participant, with long-term follow-up planned under the study protocol.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immune response, and early clinical effects of BNT3212, both alone and combined with pumitamig, in adults with advanced solid tumors who have exhausted other treatment options. This first-in-human, open-label study includes dose escalation and expansion phases to find the best dose and assess how the treatments work across different tumor types. The study is divided into four parts Part A and Part B focus on BNT3212 as a single therapy, with dose escalation followed by dose expansion in specific tumor types. Parts C and D evaluate the combination of BNT3212 with a fixed dose of pumitamig, again starting with dose escalation and then expansion cohorts. Treatments are given by intravenous infusion, and doses are adjusted to find the maximum tolerated dose and recommended dose for further study. Participants will undergo regular monitoring including safety assessments, blood tests to study drug levels and immune reactions, and imaging to measure tumor response. Researchers will track side effects, treatment interruptions, and response rates over approximately 31 months. The study also measures progression-free and overall survival. Continuous evaluation of safety and clinical data supports participant well-being throughout the trial.

Researchers are evaluating the safety and effectiveness of sunvozertinib compared to a placebo as additional treatment after surgery in patients with early-stage non-small cell lung cancer NSCLC who have specific EGFR mutations called exon 20 insertion or PACC mutations. This phase 3 study includes patients who have had complete tumor removal and may or may not have received chemotherapy before. Participants will be randomly assigned to receive either sunvozertinib or a matching placebo taken orally once daily in 21-day treatment cycles. Treatment will continue until disease recurrence, unacceptable side effects, completion of three years of therapy, or other study endpoints such as withdrawal or death. The study is double-blind, meaning neither patients nor researchers know which treatment is given. During the trial, participants will be monitored regularly through evaluations including disease-free survival assessed up to approximately five years after the first patient is enrolled. Safety will be closely watched for up to three years, including tracking adverse events and measuring sunvozertinib levels in the blood. Participants will have surgery recovery and organ function assessed before starting treatment, and follow-up will continue long-term to understand treatment impact.

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 evaluating the preliminary safety and effectiveness of AL8326 tablets combined with Toripalimab in patients who have advanced recurrent or metastatic solid tumors. This open, non-randomized phase IIIa trial aims to find the recommended phase II dose and assess objective remission rates among these patients who have limited treatment options or have experienced progression after standard therapies. The study has two parts Phase 1 involves sequential cohorts receiving AL8326 plus Toripalimab 240 mg in 28-day cycles, with dose escalation based on tolerance. Phase 2a continues treatment with AL8326 administered orally daily at the recommended dose alongside Toripalimab 240 mg given in 21-day cycles. Treatment cycles continue for up to 24 months or until disease progression or unacceptable toxicity. Participants will undergo regular assessments including tumor response evaluations every 2 to 4 cycles depending on the phase, along with safety monitoring and laboratory tests. Outcomes measured include remission rates, duration of remission, disease control, progression-free survival, and overall survival. The study requires participants to comply with follow-up procedures and safety evaluations throughout the treatment and observation periods.

Researchers are studying HLX43 an anti-PD-L1 antibody linked to a potent DNA topoisomerase I inhibitor combined with Serplulimab an anti-PD-1 antibody injection in patients with advanced or metastatic solid tumors, including non-small cell lung cancer. This open-label phase IbII clinical trial aims to find the right dosage and assess the safety, tolerability, and effectiveness of this combination treatment. The study has two parts phase Ib for dose escalation and phase II for dose expansion. Participants will receive different doses of HLX43 plus a fixed 300 mg dose of Serplulimab by intravenous infusion every three weeks. Those with good tolerance and disease control will continue treatment every three weeks until disease progression, intolerable side effects, new anti-tumor therapy start, death, or consent withdrawal. Participants will undergo regular assessments including tumor measurements by RECIST 1.1, PD-L1 expression testing from tumor samples, and monitoring of adverse events. Researchers will evaluate dose-limiting toxicity within 21 days after the first dose, maximum tolerated dose over about 12 months, and overall response rate up to 24 weeks. They will also track survival, disease progression, and safety outcomes throughout the study, which may last over two years.

Researchers are evaluating YL201, a drug being studied for men with metastatic castration-resistant prostate cancer mCRPC, in an open-label, multicenter phase II trial in China. The study aims to assess the safety, effectiveness, and how the body processes YL201 in this patient group. This research includes patients who have progressed despite prior hormone therapies and may have received limited chemotherapy. The study is sponsored by MediLink Therapeutics Suzhou Co., Ltd. Participants will receive YL201 through intravenous infusion every three weeks, with dosing schedules varying between once or twice per cycle depending on the group. There are multiple dosing cohorts testing different amounts and frequencies of YL201 to find the best dose for future studies. The trial includes about 100 patients divided into initial groups receiving specific doses and a later group receiving the recommended dose and administration method. During the study, participants will undergo regular assessments including imaging scans to measure tumor response and progression, blood tests to monitor drug levels and side effects, and evaluations of prostate-specific antigen PSA levels. Researchers will track objective response rates, progression-free survival, and safety outcomes over approximately 36 months. Tumor tissue analysis for B7H3 expression and monitoring for adverse events will also be part of the study. Participants must comply with scheduled visits and procedures throughout the trial.

Researchers are studying the effectiveness and safety of combining RC108 with Furmonertinib compared to Furmonertinib alone for treating patients with a specific type of advanced or recurrent non-small cell lung cancer NSCLC that has both EGFR mutations and MET positivity. This phase II clinical trial aims to better understand how these treatments work together for this condition. The trial involves two groups one receiving RC108 combined with Furmonertinib, and the other receiving Furmonertinib alone. Participants have unresectable locally advanced or recurrent metastatic NSCLC with certain EGFR mutations and MET positivity. Treatment and monitoring occur over several months, with careful evaluation of drug effects and safety. Participants will undergo tests for tumor response, survival rates, and disease control over a period of up to 45 months. Researchers will collect tissue samples, monitor side effects, and assess drug levels and immune responses. The study includes regular check-ins to measure how well the cancer responds and to track any adverse events or reactions.