Wu Xi Shi

Researchers are evaluating 3D1015 Injection Lu 177-PSMA-3D1015 in adult males with prostate-specific membrane antigen PSMA-positive metastatic castration-resistant prostate cancer mCRPC. This open-label clinical study aims to assess the safety, tolerability, and dosimetry of the injection while also exploring its preliminary anti-tumor effects and the best dosing strategy. The study is led by Chunjing Yu and focuses on patients with advanced prostate cancer who have shown progression despite prior treatments. Participants will receive intravenous infusions of the 3D1015 drug, with doses tailored individually to optimize safety and outcomes. The treatment period lasts approximately 36 to 48 weeks, during which the dose and schedule may be adjusted. This is a phase 1 study without placebo or control groups, focusing on detailed monitoring of treatment effects and side effects. During the study, participants will undergo regular assessments including scans and laboratory tests to monitor the absorbed radiation dose, effective half-life of the drug, and any adverse events. Researchers will also track prostate-specific antigen PSA changes, tumor response rates, and progression-free survival for up to five years. Safety and treatment effects will be carefully recorded throughout treatment and follow-up periods, with total participation lasting several years for ongoing evaluation.

Researchers are studying 89Zr-TLX250, a diagnostic imaging agent, to detect clear cell renal cell carcinoma ccRCC in Chinese patients with indeterminate renal masses. This Phase 3, open-label, single-arm study aims to confirm the safety, tolerability, sensitivity, and specificity of 89Zr-TLX250 PETCT imaging. The study supports prior ZIRCON trial data and involves adult patients scheduled for partial or total nephrectomy as part of their standard care. Participants will receive a single intravenous dose of 37 MBq of 89Zr-TLX250 containing 10 mg of girentuximab. Imaging of the abdomen using PETCT will be performed 5 days post-administration, with possible whole-body imaging if widespread disease is suspected. Nephrectomy will occur any time after imaging but within 90 days. Histological analysis of tumor samples will confirm diagnosis. The study includes approximately seven visits over 4 to 6 months. Assessments include baseline exams, PETCT imaging, surgery, and follow-up visits. Imaging and histological data will be centrally analyzed to evaluate diagnostic accuracy. Safety and tolerability will be monitored throughout. The study is expected to last about 12 months with 4 months of follow-up per participant.

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 safety and effectiveness of a drug called B007 compared to cyclosporine in treating adults with primary membranous nephropathy, a kidney condition. This study is a multicenter, randomized, controlled, open-label trial conducted in phases II and III to better understand treatment options for this disease. Participants will be randomly assigned to receive either B007 or cyclosporin capsules. B007 is given by subcutaneous injection on days 1 and 15, while cyclosporin capsules are taken orally at a dose of 3.5 mg per kg of body weight per day. The study will observe participants over about two years to assess remission rates and monitor safety. During the trial, participants will undergo laboratory tests and assessments to track overall, complete, and partial remission rates. Researchers will also monitor any treatment-emergent adverse events or serious side effects. Participants must meet specific kidney function criteria and will be followed closely throughout the study period until its completion in late 2026.

Researchers are evaluating the efficacy and safety of SPH5030 tablets in adults with Her2-positive or Her2-mutated biliary tract or colorectal cancer. This phase II clinical study focuses on patients with metastatic, unresectable, or advanced forms of these cancers who have specific genetic markers and meet certain health criteria. The study is sponsored by Shanghai Pharmaceuticals Holding Co., Ltd and aims to better understand treatment outcomes in this group. Participants will receive SPH5030 tablets orally once daily at a dose of 600 mg. The study is open-label and single-arm, meaning all participants receive the same treatment without a placebo group. The treatment period and follow-up span approximately two years, during which multiple outcome measures will be assessed. During the study, participants will undergo regular evaluations to monitor tumor response, duration of remission, disease control, progression-free survival, overall survival, and any adverse events related to treatment. Researchers will also assess safety through clinical and laboratory tests. The total involvement for each participant is about two years, allowing for detailed observation of treatment effects and tolerability.

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 and effectiveness of TQ05105 Tablets combined with TQB3617 Capsules in people with intermediate- and high-risk Myelofibrosis, a type of bone marrow cancer. This open, single-arm, multi-center clinical trial is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and aims to find the best dose and measure improvements in spleen size and symptoms over time. Participants will take TQ05105 Tablets, which target Janus kinase 1 and 2 enzymes, together with TQB3617 Capsules, which inhibit bromodomain and extra-terminal proteins. Both medications are taken orally in 21-day treatment cycles. The study includes an initial phase to determine the maximum tolerated dose and recommended dose, followed by longer evaluation periods lasting up to 120 weeks. During the study, participants will undergo regular assessments including measurement of spleen volume, symptom questionnaires, gene mutation analysis, and monitoring of side effects. The main outcomes focus on spleen volume reduction and symptom improvement, as well as survival and safety over the study period. Total participation may last up to two years, with ongoing monitoring to evaluate treatment response and tolerability.

Researchers are evaluating BG-C137, an antibody-drug conjugate targeting FGFR2b, in people with advanced solid tumors. This study aims to assess the safety, tolerability, how the drug moves and acts in the body, and early antitumor effects. It is a phase 1ab trial involving participants with tumors expressing FGFR2b or FGFR2 gene amplification who have received prior cancer treatments. The study is sponsored by BeOne Medicines and includes two main phases dose escalation and dose expansion. The trial has three parts Phase 1a evaluates increasing doses of BG-C137 alone and then in combination with other anticancer agents to establish safe dose levels. Phase 1b further explores the recommended dose in selected patient groups. BG-C137 and anticancer agents are given intravenously or orally depending on the treatment. Participants undergo dose escalation, safety expansions, and dose confirmations to determine the best dosing for further study. Participants will be monitored regularly for side effects and response to treatment for up to about two years. Assessments include measuring adverse events, drug levels in the blood, tumor response, and immune reactions to the drug. Safety follow-up visits occur after treatment ends. Researchers will measure outcomes such as maximum tolerated dose, overall response rate, disease control, and progression-free survival. The trial involves frequent visits for treatment and assessments throughout the study period.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are evaluating the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not progressed after receiving definitive concurrent chemoradiotherapy cCRT. This phase III, randomized, open-label global study aims to assess whether volrustomig can improve outcomes in this patient population. Participants are randomly assigned to one of two groups those who receive volrustomig as sequential therapy, and those who undergo observation without additional treatment. The study compares these two approaches following prior curative concurrent chemoradiotherapy. The trial includes long-term follow-up to monitor patient outcomes. During the study, participants will be regularly assessed for progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also monitor for the presence of anti-drug antibodies and adverse events related to volrustomig. Follow-up evaluations may continue for up to approximately eight years to fully understand the treatment impact and safety profile.