Wu Xi Shi

Researchers are evaluating 3D1015 Injection (Lu 177-PSMA-3D1015) in adult males with metastatic castration-resistant prostate cancer (mCRPC) that is positive for prostate-specific membrane antigen (PSMA). This open-label Phase 1 study aims to assess the safety, tolerability, and radiation dosimetry of the injection while also exploring preliminary anti-tumor effects and determining the best dosing schedule for patients. Participants will receive intravenous infusions of 3D1015 with doses tailored individually to optimize safety and treatment outcomes. The study focuses on monitoring treatment responses and adjusting therapy dynamically. No comparator group is mentioned, as this is primarily a safety and dosage evaluation study. Throughout the approximately 36 to 48 weeks of treatment, participants will be closely monitored for the occurrence and severity of treatment-emergent adverse events and dose-limiting toxicities. Researchers will also measure the absorbed radiation dose and the effective half-life of the drug. Patients will undergo regular visits for assessments to track safety, treatment effects, and drug behavior within the body.

Researchers are evaluating the effectiveness and safety of 68Ga-PSMA-11 PET/CT or PET/MRI scans in detecting biochemical recurrence of prostate cancer in Chinese male patients. This prospective, open-label, single-arm, multicenter phase 3 study focuses on patients who have experienced a rise in PSA levels after radical prostatectomy or radical radiotherapy. The study aims to assess how accurately 68Ga-PSMA-11, a new tracer called Illuccix®, identifies recurrent prostate cancer compared to histopathology, PSA monitoring, and conventional imaging over a 12-month period. Participants receive a single intravenous dose of 68Ga-PSMA-11 ranging from 111 to 259 MBq administered over 3 to 5 minutes. PET/CT or PET/MRI scans are then performed between 50 and 100 minutes after the injection. These imaging procedures help detect tumor recurrence at the patient level. The study does not mention additional treatment or comparator groups. It is conducted across multiple centers in China, focusing on this specific patient population. During the study, participants undergo scheduled PET scans and clinical monitoring including PSA measurements and follow-up imaging to confirm the presence of recurrent tumors. The main outcome measured is the positive predictive value of the imaging tests for detecting prostate cancer recurrence confirmed by biopsy, clinical markers, or imaging over one year. Safety and tolerability of the tracer and imaging procedures are also observed to ensure participant well-being throughout the study.

This will be a confirmatory, prospective, open-label, single-arm, multi-centre study in a Chinese patient population. The study is designed to evaluate the safety, tolerability, sensitivity and specificity of 89Zr-TLX250 Positron Emission Tomography/Computed Tomography (PET/CT) imaging to non-invasively detect Clear Cell Renal Cell Carcinoma (ccRCC). The multi-centre study will be conducted in mainland China in adult patients with Indeterminate Renal Masses (IRM), who are scheduled for partial or total nephrectomy as part of their standard of care. Approximately 82 evaluable adult patients will be recruited from approximately 8 renal cancer care specialist centres with access to state-of-the-art PET/CT imaging in mainland China. The number of enrolled participants may be increased to ensure sufficient confidence in measuring sensitivity and specificity of 89Zr-TLX250 PET/CT imaging. The study involves a single administration of 37 MBq (±10%) of 89Zr-TLX250, containing a mass dose of 10 mg of girentuximab, in mainland Chinese participants (ZIRCON-CP). This is consistent with the confirmatory, prospective, multinational clinical trial ZIRCON (ClinicalTrials.gov ID: NCT03849118). This study consists of seven visits. Imaging will then be conducted 5±2 days post administration. The partial/total nephrectomy will then be performed at institutional discretion any time following the PET/CT imaging visit, but no later than 90 days post administration of 89Zr-TLX250. Histological tumour samples will be prepared and used for histological diagnosis of the renal mass (ccRCC or non-ccRCC) read by a central laboratory. On Day 5±2 post study drug administration, an abdominal PET/CT imaging will be obtained. In patients, in which unexpected evidence for disseminated disease is observed, PET/CT imaging may be extended to complete whole body imaging(vertex of skull to toe) at the discretion of the investigator. Image data analyses will be performed by a central imaging vendor. For participants who were nephrectomised within 28 days post administration, the final study visit will be conducted on Day 42 (±7 days). For participants with nephrectomy between 28 and 90 days post administration, the final study visit will be performed 35 days (±7 days) after surgery. Image data analyses will be performed by a central image core lab. Qualitative visual analysis (presence or absence of localised 89Zr-TLX250 uptake inside or in vicinity of renal lesion, as seen on contrast-enhanced CT or Magnetic Resonance Imaging \[MRI\]), will be used to assess test performance or 89Zr-TLX-250 PET/CT imaging to non-invasively detect ccRCC, using histological results from the central histological reference laboratory as standard of truth. The duration of this study is expected to be about 12 months, with a follow-up of 4 months. The study duration for a single participant will be approximately between 4 - 6 months. No interim analysis is planned for this 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 safety and effectiveness of SPH5030 tablets in patients with Her2-positive or mutated biliary tract or colorectal cancer. This Phase II clinical trial focuses on people with metastatic or advanced forms of these cancers who meet specific health criteria and have not previously received certain targeted therapies. Participants will receive SPH5030 tablets orally once daily at a dose of 600 mg. The study is designed as a single-arm, open-label trial conducted at multiple centers. Treatment continues as per protocol, with patients monitored for response and safety throughout the study period. During the trial, participants will be regularly assessed for their response to treatment, including the objective response rate over approximately two years. Researchers will monitor safety, side effects, and overall health through clinical evaluations and laboratory tests. The study includes ongoing observation to evaluate the drug's impact and patient well-being during and after treatment.

Researchers are evaluating the safety and effectiveness of combining TQ05105 Tablets and TQB3617 Capsules in patients with intermediate- and high-risk Myelofibrosis. This open, single-arm, multi-center clinical trial is conducted in Phase Ib/II to study this combination treatment in adults with this condition. The goal is to find the best dose and assess how well the treatment works, including measuring spleen size reduction. The study treatment includes TQ05105 Tablets, which inhibit Janus kinase 1 and 2, and TQB3617 Capsules, which inhibit Bromodomain and Extra-Terminal proteins. Participants receive these drugs together, but specific dosing schedules are not detailed in the provided information. The study includes multiple phases to evaluate safety and dose levels for up to two years. Participants will undergo various assessments, including measuring spleen volume changes and determining maximal tolerated doses. The main outcomes include the recommended phase II dose and spleen volume reduction over 24 weeks and up to two years. Safety monitoring and evaluation of symptom scores are also part of the follow-up during the study period, helping researchers understand the treatment impact and tolerability.

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.

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

Researchers are conducting a phase 3 study to evaluate the safety and effectiveness of orforglipron for treating hypertension in adults who are overweight or have obesity. The study framework supports two independent trials and aims to better understand how orforglipron works in this specific population with high blood pressure and excess weight. Participants receive orforglipron or a placebo orally once daily. The study includes screening and baseline visits to confirm eligibility based on blood pressure and body mass index. Treatment is randomized and double-blind, meaning neither participants nor researchers know who receives the active medication or placebo during the trial. Throughout the study, researchers monitor blood pressure and other health factors to assess the number of participants assigned to each treatment group. Safety and efficacy are evaluated regularly, with ongoing observation of participants’ response to the medication and any potential side effects.