Binzhou

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 the effectiveness and safety of combining RC108 with Furmonertinib compared to using Furmonertinib alone for first-line treatment in adults aged 18 to 75 years with EGFR-mutated, MET-positive, unresectable locally advanced or recurrent metastatic non-small cell lung cancer (NSCLC). This Phase II trial aims to provide new options for patients whose cancer cannot be removed by surgery or treated with radiation. The study also looks at how the body processes RC108 and whether the immune system reacts to it when given with Furmonertinib. Participants will be randomly assigned to receive either the combination of RC108 and Furmonertinib or Furmonertinib alone. Treatments are taken as medications, and the study monitors patients over time to compare their responses. The study includes patients who have not received previous systemic therapy for their advanced or recurrent disease. Tumor tissue samples are collected for testing, and participants must have measurable cancer lesions. During the study, participants will undergo regular assessments including physical exams, performance status evaluation, and tumor measurements according to RECIST criteria. Researchers will track the objective response rate over 24 months to determine how well the treatments work. Safety will be closely monitored along with patient survival and overall health. Participants are expected to use effective contraception if of childbearing potential and will be followed for treatment effects and side effects throughout the study period.

Bladder cancer, primarily bladder uroepithelial cancer, is a common genitourinary tumor with a high recurrence rate, especially for non-muscle-invasive bladder cancer (NMIBC), which accounts for about 75% of cases. This research evaluates how drug sensitivity testing using patient-derived bladder cancer organoids can guide individualized bladder perfusion chemotherapy to improve treatment selection and reduce recurrence. The study is designed as a multicenter cohort study and aims to compare recurrence-free survival rates among patients receiving organoid-sensitive chemotherapy, organoid-non-sensitive chemotherapy, and BCG therapy. Patients undergo organoid culture from tumor tissue collected during surgery to test sensitivity to several chemotherapeutic agents including gemcitabine, piroxicam, epirubicin, mitomycin, and doxorubicin. Based on organoid drug sensitivity results, patients are assigned to either an organoid-sensitive drug perfusion group or an organoid-non-sensitive drug perfusion group. Chemotherapy regimens include induction perfusion weekly for 4 weeks starting 4 to 8 weeks post-surgery, followed by maintenance perfusion monthly for 11 months. The BCG group receives a series of infusions over one year including induction, booster, and maintenance doses. Participants are closely followed with regular cystoscopy based on their risk level to monitor tumor recurrence and progression over one and three years. Assessments include clinical efficacy evaluations using established criteria and survival analysis to compare recurrence rates. Safety and adverse events are recorded, and data management and quality control measures are applied. The study duration includes treatment, follow-up, and outcome measurement periods up to three years to explore the value of organoid-guided therapy in precision bladder cancer treatment.

Researchers are evaluating the effectiveness and safety of BGB-16673 compared to the investigator's choice of treatment (either bendamustine plus rituximab or high-dose methylprednisolone plus rituximab) in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with covalent Bruton tyrosine kinase inhibitors. CLL and SLL are blood cancers that cause enlarged lymph nodes, spleen, or liver and symptoms such as night sweats, weight loss, and fever, leading to a shorter life expectancy. Participants will be randomly assigned to receive either oral BGB-16673 or the investigator's choice of intravenous bendamustine plus rituximab or high-dose methylprednisolone plus rituximab. About 150 participants in Mainland China and Taiwan will take part in this Phase 3, open-label, randomized study. During the study, researchers will measure how long participants live without their disease worsening, known as progression-free survival, over approximately 23 months. Participant health and disease status will be monitored through imaging, laboratory tests, and clinical assessments to evaluate treatment effects and safety.

This research aims to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and its safety and effectiveness in adults with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study focuses on participants who meet specific IBS-D criteria related to bowel movement patterns and abdominal pain. It is a Phase 2, randomized, double-blind, placebo-controlled trial lasting approximately 35 weeks. Participants will receive either brenipatide or a placebo, both administered under the skin through subcutaneous injection. The treatments are compared to assess their impact on IBS-D symptoms. The study involves careful monitoring of patients' responses to the medication over the treatment period, with no changes in diet allowed in the four weeks before screening. During the study, participants will track their symptoms daily using an electronic diary, including abdominal pain and stool consistency. Researchers will measure the percentage of days participants have a positive composite response between weeks 9 and 16. Safety and side effects will be monitored throughout the study, ensuring participants are closely observed during the full duration of about 35 weeks.

This Phase III, randomized, open label, multicenter study will evaluate the efficacy and safety of SIM0270 combined with everolimus compared to physician's choice of treatment in subjects with ER+/HER2- locally advanced or metastatic breast cancer who have had previous treatment with CDK4/6 inhibitor.

This is a multi-center, randomized, double-blind, placebo-controlled Phase 3 study. Participants who fulfill the inclusion and exclusion criteria will be enrolled at up to 35 study sites in mainland China. All eligible participants will be randomized in a 2:1 ratio to HST101 or placebo dosed subcutaneously (Q4W \[≤31 days\]) in the initial 12-week randomized double-blind treatment period. After 12-week treatment, all the participants will enter to the 36-week open-label treatment period where those who are on HST101 will continue to receive HST101 in the same dosing regimen as dosed in the randomized period, and those who are on placebo will be switched to HST101 300 mg (Q4W \[≤31 days\]) administered subcutaneously. The total study duration will be up to 55 weeks which includes a up to 3-week Screening Period, 12-week randomized, double-blind, placebo-controlled treatment period, 36-week open-label treatment period, followed by a 4-week follow-up period.

Researchers are evaluating the efficacy and safety of Live SK08 Powder compared with a placebo in treating adults aged 18 to 70 years with irritable bowel syndrome with diarrhea (IBS-D). IBS is a chronic condition causing abdominal pain, bloating, and changes in bowel habits without detectable lesions. SK08 may help by protecting the intestinal barrier, regulating immune responses, reducing inflammation, and correcting bacterial imbalances. Participants will receive either Live SK08 Powder or a placebo in oral powder form during the study. The study is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial. Participants must have recently completed a colonoscopy and meet specific symptom criteria based on the Rome IV definition for IBS-D. During the run-in period, patients will document their symptoms in diaries and must meet pain and stool frequency thresholds before randomization. Throughout the 12-week study, researchers will monitor the percentage of patients who respond weekly to treatment and track adverse and serious adverse events up to 52 weeks. Participants will complete daily diaries and undergo various clinical assessments to evaluate symptoms, safety, and treatment effects. They are asked to maintain their usual diet and lifestyle during the study and avoid certain medications that could affect gastrointestinal function.

Researchers are evaluating the effectiveness and safety of RO7837195 in adults with moderately to severely active ulcerative colitis who have not responded well or tolerated conventional or advanced treatments. This Phase IIb study aims to compare RO7837195 to a placebo during the initial treatment phase and then monitor all participants receiving the active drug to assess clinical remission at 12 weeks. The study includes a screening period lasting up to 5 weeks, followed by a 12-week induction phase where participants receive either RO7837195 or a matching placebo according to a specified schedule. After this induction phase, all participants enter a 40-week active treatment extension where they receive RO7837195 regardless of their earlier response. A safety follow-up period occurs after the last dose to continue monitoring participant health. Participants will undergo assessments throughout the study to measure clinical remission at week 12 and to monitor safety and pharmacokinetics. Researchers will collect data on symptoms, treatment effects, and any side effects experienced. The total participation involves multiple phases designed to carefully evaluate the long-term impact and safety of RO7837195 in ulcerative colitis management.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.