Wei Fang Shi

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 effectiveness and safety of TQB2102 for injection compared to a standard chemotherapy regimen called TCbHP in patients with HER2-positive breast cancer. This phase III, randomized, open-label, multi-center study focuses on neoadjuvant treatment, which is therapy given before surgery. The study aims to measure the total pathological complete response and other outcomes such as event-free survival and overall survival. Participants receive either TQB2102 for injection at 6 mgkg by intravenous infusion every 3 weeks for 8 cycles or a combination of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin given intravenously every 3 weeks for 6 cycles. The study monitors participants throughout the treatment period and collects data on tumor response and side effects. During the study, participants will undergo assessments including tumor response evaluations by independent review and investigators, safety monitoring for adverse events, and laboratory tests. Follow-up will continue for up to 50 months after the start of the study to observe long-term outcomes. Participants are expected to comply with contraceptive use requirements and attend all scheduled visits for treatment and evaluations.

Researchers are evaluating the safety and effectiveness of TQB2450 injection combined with chemotherapy or anlotinib hydrochloride capsule in the perioperative treatment of resectable stage IIIII non-small cell lung cancer. This phase 2 clinical study involves patients eligible for curative surgery and aims to improve treatment outcomes using these combination therapies. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Participants are randomly assigned to one of two treatment groups. In the first group, patients receive 3 to 4 cycles of TQB2450 combined with chemotherapy every 21 days, followed by surgery 4 to 6 weeks after the last dose. TQB2450 treatment continues for one year after surgery. In the second group, participants receive 4 cycles of TQB2450 combined with 3 cycles of anlotinib hydrochloride capsule over 21-day cycles, followed by surgery 4 to 6 weeks after the last dose, with treatment continuing for one year starting 4 weeks after surgery. During the study, participants undergo tumor tissue testing for PD-L1 and regular assessments including measuring major pathologic response up to 60 months. Secondary outcomes include overall survival, event-free survival, disease-free survival, pathological complete response, and surgical outcomes, with follow-up extending up to 60 months. Patients are monitored for safety, treatment effects, and surgery timing. The total participation time may last several years to evaluate long-term results.

Researchers are evaluating the dose-effect relationship of TQH3906 capsules compared to placebo in treating active Psoriatic Arthritis PsA. This Phase II, randomized, double-blind, placebo- and active drug-controlled clinical trial aims to measure the proportion of participants achieving a 20% improvement in arthritis symptoms by Week 12, using the American College of Rheumatology ACR20 criteria as the primary endpoint. Participants are randomly assigned to receive one of several oral treatments daily from Day 1 to Day 85 either 24 mg or 16 mg of TQH3906 capsules, placebo capsules matching TQH3906, or 5 mg tofacitinib citrate tablets. The treatments are administered in the morning while fasting, with tofacitinib also taken at bedtime. This study evaluates efficacy and safety across these groups over 12 weeks of treatment. During the study, participants are assessed at multiple timepoints for improvements in arthritis symptoms ACR20, ACR50, ACR70 and psoriasis severity PASI 75 and PASI 90. Blood samples are collected to evaluate drug levels and immune markers at baseline and Weeks 2, 4, 8, and 12. Safety is monitored continuously through adverse event reporting up to 28 days after the last dose. The total study duration per participant is approximately 12 weeks of treatment plus follow-up.

Researchers are evaluating the efficacy and safety of TQH3906, a Tyrosine Kinase 2 TYK2 inhibitor, in treating systemic lupus erythematosus SLE, an autoimmune disease. This randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial aims to assess how well TQH3906 works and its safety profile in adults diagnosed with SLE based on established criteria. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Participants are randomly assigned to one of three groups 16 mg TQH3906 capsule, 24 mg TQH3906 capsule, or placebo. All treatments are taken orally once daily for 48 weeks. The trial compares these doses to placebo to understand TQH3906s impact on disease activity. The study uses a parallel design and includes a quadruple masking method to keep participants and researchers unaware of group assignments. During the study, participants undergo regular assessments including clinical evaluation of disease activity using the Systemic Lupus Erythematosus Responder Index 4 SRI-4, lupus activity indices, and joint assessments up to week 48. Safety is monitored throughout, and background lupus medications must remain stable during the trial. The primary outcome measure is the percentage of participants achieving SRI-4 response by week 32, with additional secondary measures assessing remission, low disease activity, and symptom improvements. Participation lasts up to 48 weeks with scheduled visits and monitoring.

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 evaluating the investigational drug HTD1801 to see if it can slow kidney damage progression in adults who have both Type 2 Diabetes T2DM and Chronic Kidney Disease CKD. The main focus is to determine if HTD1801 can reduce or limit the increase in urine albumin-to-creatinine ratio UACR compared to a placebo. This Phase 2 randomized, double-blind study aims to understand the drugs effect on kidney function decline in this population. Participants will be randomly assigned to take either HTD1801 capsules 1000mg as 4 capsules or matching placebo capsules twice daily for 12 weeks. The study involves weekly clinic visits for the first 4 weeks, followed by visits every 4 weeks, during which various assessments and check-ups are conducted. The study drug or placebo is taken orally, and safety is closely monitored through health reports and routine laboratory tests. During the study, participants will attend scheduled visits for assessments including urine and blood tests to measure kidney function and other health markers. The primary outcome measured is the relative change in UACR from baseline at 12 weeks. Secondary outcomes include changes in estimated glomerular filtration rate eGFR, albumin excretion rate, inflammatory markers, blood sugar levels, and cholesterol. Safety monitoring continues throughout the trial to track any health changes or adverse effects.

Researchers are evaluating the safety, effectiveness, and how the body processes INT-210 capsules in adults with active ulcerative colitis UC. This randomized, open-label study focuses on participants aged 18 to 75 years diagnosed with active UC, aiming to gather detailed information on the drugs pharmacokinetics and pharmacodynamics while monitoring treatment safety. Participants will receive oral INT-210 capsules in one of two doses 200 mg twice daily or 400 mg twice daily, starting from Day 1 of a 12-week treatment period. The study is designed to compare these two dosing regimens in parallel groups to assess their impact on UC symptoms and drug behavior in the body. During the study, participants will undergo various assessments including laboratory tests to monitor safety, clinical evaluations to measure remission and response rates, and pharmacokinetic sampling up to Day 85. Safety follow-up continues through Day 92 to track adverse events and important clinical parameters. Overall, participants can expect regular visits and monitoring throughout the treatment and follow-up phases lasting approximately 3 months.

Bladder cancer is a common and serious tumor that originates from the bladders lining, with the majority being non-muscle invasive bladder cancer NMIBC. NMIBC has a high recurrence rate even after initial treatment, making postoperative bladder perfusion chemotherapy important to prevent tumor return. This research evaluates the use of patient-derived bladder cancer organoids to test drug sensitivities and guide individualized chemotherapy, aiming to improve treatment effectiveness and reduce recurrence for bladder cancer patients. The study involves preparing bladder cancer organoids from tumor tissue collected during surgery. Researchers perform drug sensitivity testing on these organoids with various chemotherapeutic agents, including gemcitabine, pirenzolubicin, epirubicin, mitomycin, and doxorubicin. Based on organoid sensitivity results, patients receive bladder perfusion chemotherapy with either sensitive or non-sensitive drugs, or receive BCG vaccine infusions. Treatment schedules include induction perfusion weekly for 4 weeks and maintenance perfusion monthly for 11 months, or BCG infusions following an induction and maintenance regimen over one year. Participants undergo regular clinical assessments including cystoscopy, urine cytology, and imaging as needed to monitor tumor recurrence and progression over up to three years. Researchers analyze one-year and three-year tumor recurrence-free and progression-free survival rates among groups. The study monitors patient compliance, adverse events, and clinical outcomes to assess the value of organoid drug sensitivity testing in guiding personalized bladder cancer perfusion chemotherapy.

Researchers are comparing two treatment combinations for adults with advanced nonsquamous non-small cell lung cancer NSCLC that have a specific KRAS p.G12C mutation and are negative for PD-L1 expression. The study aims to evaluate progression-free survival and overall survival between participants receiving sotorasib with platinum doublet chemotherapy and those receiving pembrolizumab with platinum doublet chemotherapy. This phase 3, randomized, open-label trial is led by Amgen and includes participants with stage IV or advanced stage IIIBC NSCLC. Participants will be randomly assigned to receive either sotorasib orally combined with carboplatin and pemetrexed, or pembrolizumab intravenously combined with the same chemotherapy drugs. These treatments are given as front-line therapy. The study includes a treatment period with these drug combinations and monitoring for outcomes such as response rates and quality of life over several years. During the study, participants will be regularly assessed through various measures including survival status, tumor response, and quality-of-life questionnaires focusing on lung cancer symptoms. Researchers will monitor safety by tracking adverse events, vital signs, and laboratory tests. Treatment concentrations of sotorasib will also be measured up to 64 days after starting. The total study duration includes follow-up for up to approximately 5.5 years to fully evaluate treatment effects and outcomes.