Xuzhou

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are investigating a treatment for precursor B-cell Acute Lymphoblastic Leukemia (B-ALL) in patients whose cancer has either returned after treatment or stopped responding to current therapies. This study has two parts: an initial dose escalation phase to evaluate the safety and find the best tolerated dose of the drug MK-1045, followed by a Phase II part to assess how well MK-1045 works in treating B-ALL. MK-1045 is given through an intravenous infusion once a week in cycles of 4 weeks, starting with two induction cycles. After a 2-week break, patients who respond to induction receive three consolidation cycles, followed by up to seven maintenance cycles or until certain conditions occur, such as intolerable side effects, disease progression, or withdrawal from the study. Each 4-week treatment cycle is followed by a 2-week treatment-free interval. Participants will be closely monitored throughout the study, including during the dose escalation phase lasting up to about 24 months and the Phase II part lasting up to about 10 weeks. Researchers will track side effects, treatment discontinuations due to adverse events, dose-limiting toxicities, and the maximum tolerated dose of MK-1045. They will also measure the rate of complete remission to understand the drug's effectiveness in this patient population.

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 the safety, tolerability, anti-tumor effects, and pharmacokinetics of LVIVO-TaVec200 in adults with relapsed or refractory multiple myeloma who have not responded to at least three prior standard treatments. This open-label, single-arm, dose-escalation and dose-expansion study aims to better understand how this biological treatment behaves in the body and its potential impact on this condition. Participants will receive the LVIVO-TaVec200 product infusion after any necessary bridging therapy. The study includes a core period lasting about two years, covering screening, treatment, and follow-up phases. The dose of LVIVO-TaVec200 will be evaluated and adjusted during the first 30 days after infusion to determine the recommended Phase II dose. During the study, researchers will monitor the occurrence and severity of treatment-emergent adverse events as well as the pharmacokinetics of LVIVO-TaVec200 in both peripheral blood and bone marrow over approximately two years. Participants will undergo clinical laboratory tests and assessments of measurable lesions, with ongoing follow-up to track safety and treatment effects throughout the study period.

Researchers are evaluating the safety and tolerability of B019 injection in patients with relapsed or refractory B-cell acute lymphoblastic leukemia. This phase 1 clinical study aims to gather preliminary data on how well patients tolerate this treatment and to monitor its safety over approximately two years. The study includes participants aged 3 to 25 years who have documented CD19/CD22 tumor expression and meet specific health criteria. Participants will receive B019 through intravenous infusion, with doses ranging from 1.0x10^6 to 10.0x10^6 CAR T cells per kilogram of body weight. The study focuses on assessing the treatment-emergent adverse events and serious adverse events to understand the safety profile of B019. The treatment is given under close medical supervision, and participants must agree to use effective contraception if applicable. Throughout the study, researchers will monitor patients for side effects, overall health, and treatment responses. This includes regular assessments of liver, kidney, lung, and heart functions, as well as ongoing documentation of any adverse events over about two years. Participants and their guardians will provide informed consent and commit to follow-up visits and evaluations to ensure their safety and collect necessary data for the study's outcomes.

Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), and immune response (immunogenicity) of a drug called SV001 in patients diagnosed with idiopathic pulmonary fibrosis (IPF). This study is a Phase IIa clinical trial and aims to better understand how the body processes SV001 and how safe and tolerable it is for people with IPF. Participants will receive multiple doses of either SV001 or a placebo (a treatment with no active drug) during the study. The study is randomized and double-blind, meaning neither the participants nor the researchers know who receives SV001 or placebo. The dosing is planned to escalate in multiple steps to assess safety and drug behavior at different levels. During the study, participants will undergo various evaluations including monitoring for any adverse effects that arise from the treatments over approximately one year. Researchers will collect data on how the drug moves through and affects the body, immune responses, and overall safety. Participants must comply with study procedures, including using effective contraception and attending scheduled assessments throughout the study period.

Researchers are evaluating VT-101, a recombinant oncolytic adenovirus, for its safety and effectiveness in treating non-muscle invasive bladder cancer (NMIBC). This open-label, single-arm exploratory clinical trial is designed to study patients with moderate to very high risk NMIBC, focusing on determining the appropriate dosing and assessing treatment-related toxicities. The trial includes a phase 1 dose-escalation phase followed by an expansion phase, addressing the treatment needs of patients who may not be candidates for surgical removal or radical cystectomy. The study is divided into two phases. In phase 1, a climbing test with accelerated titration dosing is performed starting with a low dose of VT-101 administered by intravesical instillation once weekly. Dose escalation occurs based on observed dose-limiting toxicities during a 7-day observation period, using a 3+3 design. Participants without serious toxicities continue weekly dosing for six weeks, followed by monthly treatments for up to one year or until disease progression or other stopping criteria. Phase 2 enrolls about 8-10 participants at the recommended dose determined from phase 1, also receiving weekly intravesical instillations for six weeks with subsequent monthly treatments, adjusted as needed. During the study, participants undergo regular cystoscopy, urine cytology, urography, and biopsies as needed to monitor their condition. Safety is carefully monitored by tracking adverse events and treatment discontinuations due to toxicity up to three months after dosing. Laboratory tests, physical exams, and pregnancy tests are conducted to ensure participant health and eligibility. The trial duration may last up to one year of treatment with ongoing safety and efficacy assessments throughout this period to evaluate the impact of VT-101 on NMIBC.

Researchers are evaluating the safety and effectiveness of TQB3909 tablets in patients who have recurrent or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). This phase Ib/II clinical trial focuses on patients diagnosed according to specific criteria and aims to understand how well this treatment works and how safe it is for this population. The study investigates TQB3909, a drug designed to inhibit the B-cell lymphoma-2 (BCL-2) protein. Participants will receive TQB3909 tablets as part of the treatment regimen. The trial includes monitoring for side effects and disease response over time. The study will measure the recommended phase II dose and assess remission rates through evaluations conducted up to 34 months. Participants will be involved in assessments that include monitoring for adverse events, serious adverse events, and abnormal laboratory results. These will be tracked for up to 34 months to evaluate safety and treatment impact. The study also includes imaging tests for measurable lesions and pregnancy testing for women of childbearing potential. Overall, the trial may last up to nearly three years, with ongoing safety and effectiveness evaluations throughout.

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 the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.