Xuzhou

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Researchers are studying a new treatment called MK-1045 for people with precursor B-cell Acute Lymphoblastic Leukemia B-ALL that has returned after treatment or stopped responding to current therapies. This trial includes two parts a dose escalation phase to find the safest and most effective dose, and a Phase II part to evaluate how well MK-1045 works. The study focuses on safety, tolerability, and treatment response in both adults and children aged 2 years and older. In the dose escalation phase, adults receive MK-1045 doses ranging from 600 to 120,000 micrograms once weekly through intravenous infusion in treatment cycles of 4 weeks. Pediatric patients receive weight-based doses from 320 to 60,000 micrograms on the same weekly schedule. Treatment starts with induction cycles, followed by consolidation and maintenance phases, continuing until certain conditions such as disease progression or intolerable toxicity occur. The study is open-label and non-randomized, assessing MK-1045 administered intravenously over multiple treatment cycles. Participants will have their health closely monitored with regular assessments including adverse event tracking, blood tests, and evaluations of leukemia response. Researchers will measure outcomes such as remission rates, drug levels in the blood, immune cell activity, and survival over periods up to two years. The trial includes both adult and pediatric participants and aims to gather detailed safety and effectiveness data throughout treatment and follow-up periods.

Researchers are evaluating the effectiveness and safety of Recombinant Botulinum Toxin Type A YY001 injections for treating upper limb spasticity in adults who have had a stroke. This randomized, double-blind, multi-center phase IIIII study compares YY001 with BOTOX4 and a placebo to better understand treatment options for this condition. Participants will receive a single intramuscular injection of either Recombinant Botulinum Toxin Type A YY001 with a dose of 200-400 units, BOTOX4 with a dose of 200 units, or a placebo prepared with saline. The study includes three groups the experimental group receiving YY001, an active-controlled group receiving BOTOX4, and a placebo-controlled group. Each participant receives only one injection during the treatment period. During the study, participants will be monitored at 1, 4, 8, and 12 weeks after treatment through assessments such as the Modified Ashworth Scale MAS for spasticity, Physicians Global Assessment, and Disability Assessment Scale DAS. Researchers will also track any adverse events and the presence of antibodies to the treatment. The primary outcome is the change in MAS score at week 4. The study lasts at least 12 weeks with ongoing safety and efficacy follow-up.

Researchers are evaluating the LVIVO-TaVec200 product in a dose-escalation and dose-expansion clinical study for adults with relapsed or refractory multiple myeloma who have not responded to at least three prior standard treatments. This early phase 1 study aims to assess the safety, tolerability, anti-tumor effects, and how the product behaves in the body over time. The study is open-label and single-arm, focusing on this specific patient group with measurable disease and a reasonable life expectancy. Participants will receive a single infusion of the LVIVO-TaVec200 product at increasing dose levels. Before the infusion, some participants may receive bridging therapy if needed. The study includes a core period lasting about two years, which covers screening, bridging therapy, treatment, and follow-up phases. Researchers will monitor patients closely throughout this time to determine the recommended dose for future studies. During the study, participants will undergo various assessments, including monitoring for treatment-emergent adverse events, and testing the pharmacokinetics of the product in peripheral blood and bone marrow. These evaluations will continue through the two-year follow-up period after infusion. Participants will be regularly assessed for safety and treatment effects, with ongoing follow-up to track their response and health status throughout the study duration.

Researchers are evaluating the efficacy and safety of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight and type 2 diabetes mellitus T2DM. This Phase III study aims to better understand how enicepatide affects body weight and other health measures in this population. Participants will be randomly assigned to receive either placebo or one of three dosing regimens of enicepatide, administered once weekly using an integrated drug-device combination product. The study lasts for 72 weeks, during which participants will self-administer the study drug or receive injections from a trained individual if needed. Throughout the study, participants will undergo various assessments including body weight, hemoglobin A1c, waist circumference, fasting glucose and insulin, cholesterol levels, blood pressure, and quality of life questionnaires. Safety will be monitored through adverse event reporting and specific rating scales. This comprehensive evaluation will help determine the effects of enicepatide on weight and diabetes management over the study period.

Researchers are evaluating the safety, tolerability, and early effects of B019 injection in individuals aged 3 to 25 years with relapsed or refractory B-cell acute lymphoblastic leukemia. This phase 1 clinical study is sponsored by Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd. and aims to gather important information about the treatments impact on this serious blood cancer. Participants receive B019 through an intravenous infusion at doses ranging from 1.0 x 106 to 10.0 x 106 CAR T cells per kilogram. The study focuses on monitoring any treatment-related side effects and serious adverse events over about two years. The research team also examines how the body processes the treatment and measures overall survival and response rates within this period. During the trial, participants will be observed for up to two years to track safety and treatment outcomes. Researchers will collect data on adverse events, overall response to the therapy within three months, and survival over two years. The study includes regular health assessments and laboratory tests to monitor organ function and treatment effects, ensuring careful safety follow-up throughout the study duration.

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, and immune response of a drug called SV001 in patients with idiopathic pulmonary fibrosis IPF, a lung condition. This Phase IIa clinical trial is randomized, double-blind, and placebo-controlled, aiming to gather detailed information about how the drug behaves in the body and its safety profile. Participants will receive multiple doses of SV001 or a placebo, with the study designed to compare these groups. The treatment period includes escalating doses to assess how the drug is tolerated and processed by the body. The study will last approximately one year, during which participants will be closely monitored. During the trial, participants will undergo regular assessments including checking for treatment-related adverse events, measuring the drug concentration in blood over time, and testing for immune responses. The main outcome is the incidence of adverse events over about one year. Additional evaluations will look at peak drug levels, time to peak levels, drug exposure over time, half-life, and immunogenicity. Safety and tolerability will be continuously monitored throughout the study period.

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 evaluating VT-101, an experimental recombinant oncolytic adenovirus therapy, for treating non-muscle invasive bladder cancer NMIBC. This open-label, single-arm exploratory phase 1 clinical trial aims to assess the safety and efficacy of VT-101 in patients with moderate to very high-risk NMIBC, including those who may be medically unfit or refuse standard surgeries. The study is sponsored by The Affiliated Hospital of Xuzhou Medical University. The trial is divided into two phases. Phase 1 uses an accelerated titration dose escalation design starting with a low dose, increasing doses cautiously while monitoring for dose-limiting toxicities DLT over 7-day periods. Participants who tolerate the doses receive weekly intravesical instillations for six weeks, with possible monthly maintenance dosing up to one year unless progression, toxicity, withdrawal, or other criteria occur. Phase 2 expands enrollment based on the recommended dose from phase 1, including patients with unresectable high-risk NMIBC, following a similar dosing schedule. Participants undergo regular evaluations including cystoscopy, urine cytology, urography, and biopsy as needed. Researchers will monitor adverse events, treatment discontinuations due to toxicity, and tumor response rates such as complete or partial response and disease progression. Safety and efficacy are primarily assessed three months after treatment. The total participation time depends on treatment continuation and follow-up requirements, with careful safety monitoring throughout the study.

Researchers are investigating a combination therapy of BNT326 and pumitamig also called BNT327 or PM8002 in adults with advanced or metastatic non-small cell lung cancer NSCLC who may have relapsed, progressive, or treatment-nafve disease. This multi-site, open-label study aims to find the best dose levels for this combination, assess how well participants tolerate the therapy, including side effects, and evaluate its ability to shrink tumors in this population. The study has three parts Part 1 focuses on finding safe dose levels for the combination Part 2a expands the dose evaluation to assess preliminary effectiveness and safety Part 2b is a randomized phase to optimize doses and understand the contribution of each drug component. Participants will receive intravenous infusions of BNT326 and pumitamig or pumitamig alone in some arms. Treatment continues until disease progression, unacceptable side effects, withdrawal, study end, or up to 24 months. Dose levels for later parts are chosen based on earlier safety and efficacy data. Participants will go through screening, treatment, safety follow-up, efficacy follow-up, and long-term survival follow-up phases, with total involvement expected to last about 36 months unless treatment benefit continues. Assessments include monitoring for dose-limiting toxicities, adverse events, tumor response, progression-free survival, overall survival, and pharmacokinetics of the drugs. Safety evaluations continue up to 90 days after treatment ends, and antibody responses to the drugs are also measured for up to one year post-treatment.