Ji Nan Shi

Researchers are investigating elderly female patients aged 65 years and older with Luminal A type breast cancer that has spread to lymph nodes after surgery. This observational study aims to assess whether a 21-gene assay can predict survival outcomes and the benefits of chemotherapy in these patients. The study focuses on clinical and pathological data including imaging, treatment plans, and medication strategies to better understand disease progression and treatment impact. The study collects paraffin tissue samples from both the primary breast cancer and metastatic lymph nodes for a 21-gene assay, which calculates a recurrence risk index. Patients will be followed every 12 months after surgery to monitor for disease recurrence. After recurrence, survival is followed every three months until death. This approach allows researchers to observe real-world treatment effects and outcomes without administering experimental treatments. Participants will have their clinical information and treatment details recorded, including whether chemotherapy, radiotherapy, endocrine therapy, or targeted therapy were used after surgery. Follow-up includes regular assessments and survival tracking until the patient reaches age 80 or passes away. Data collected will help evaluate the predictive value of the 21-gene assay and guide treatment decisions for elderly breast cancer patients with lymph node involvement.

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, tolerability, dosimetry, and preliminary effectiveness of 225AcAc-FAPI-XT injection in patients with advanced solid tumors that express fibroblast activation protein FAP. This early-phase clinical study focuses on patients whose cancer has progressed despite standard treatments or who lack effective standard options. The trial aims to better understand how this targeted therapy behaves in the body and its potential impact on tumor control. Participants will receive doses of 225AcAc-FAPI-XT also called XT117 given every 6 weeks. This is a single-arm study, meaning all participants receive the same investigational drug without a comparison group. The treatment targets FAP-positive tumors and involves monitoring for any side effects and measuring tumor response over time. The study treatment is administered under careful medical supervision to assess tolerance and possible benefits. Throughout the study, participants will undergo regular evaluations including scans, laboratory tests, and clinical assessments to monitor safety and tumor response. Researchers will track side effects and dose-limiting toxicities for up to two years following treatment. They will also measure outcomes such as overall response rate, duration of response, disease control rate, and progression-free survival. This comprehensive monitoring helps understand the treatments profile and guides future development. Total participation duration varies based on individual response and study timelines.

Researchers are conducting a Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetic profile of AK0610 in healthy Chinese adults aged 18 to 50. The study is randomized, double-blind, and placebo-controlled, focusing on single-dose administration with dose escalation and expansion phases. The trial involves healthy volunteers to understand how the body processes AK0610 and to monitor any side effects. The trial has two parts a dose-escalation phase with five cohorts receiving increasing doses of AK0610 or placebo either intramuscularly or intravenously, and an expansion phase with two additional cohorts based on pharmacokinetic data. Doses range from 100 mg to 3000 mg, administered once on Day 1. Participants receive either AK0610 or placebo in a 31 ratio in all cohorts. Participants undergo a screening period from Day -29 to Day -1, followed by the dosing on Day 1 and an inpatient observation period until Day 8. Afterward, there is a blinded follow-up period lasting until Day 181, with those receiving AK0610 entering an open-label period from Day 182 to Day 361. Researchers will monitor adverse events, measure serum drug concentrations, and assess immunogenicity and RSV-neutralizing activity throughout the study.

Researchers are evaluating the effectiveness and safety of B001 injection in patients who have neuromyelitis optica spectrum disorder NMOSD and test positive for aquaporin-4 antibodies. This condition involves recurrent attacks affecting the nervous system. The study is a multicenter, randomized, double-blind, placebo-controlled trial conducted in phases II and III to understand how well B001 works and how safe it is for these patients. Participants will receive intravenous doses of either B001 or a placebo on Day 1 and Day 15 during the randomized controlled period. The study includes two groups one receiving B001 injections and the other receiving placebo injections matching B001s schedule. The trial will extend over several years, monitoring patients closely for disease relapse and treatment side effects. During the study, participants will be regularly assessed for the time to their first NMOSD attack, changes in disability status, vision acuity, and opticospinal function. Researchers will also observe the annual relapse rate and document any adverse events. The trial includes safety monitoring for about three years to ensure comprehensive data collection on treatment impact and participant health.

Researchers are evaluating the effectiveness and safety of B007 in people with generalized myasthenia gravis, a condition that causes muscle weakness. This randomized, double-blind, placebo-controlled Phase IIIII study aims to understand how well B007 works compared to a placebo in improving daily living activities affected by this condition. Participants will receive either a high or low dose of B007 or a matching placebo through subcutaneous injections on days 1 and 15. The study includes careful monitoring over approximately 16 to 24 weeks to assess changes in symptoms and quality of life, with a safety follow-up lasting about one year. During the trial, participants will be evaluated through various measures including the Myasthenia Gravis-Activities of Daily Living profile, quality of life questionnaires, and composite scores related to the condition. Researchers will also track any side effects or adverse events. The total participation time varies, with key assessments occurring around 16 to 24 weeks and safety monitored for about a year.

Researchers are evaluating the efficacy and safety of a drug called B007 in adults with pemphigus, a condition characterized by blistering of the skin and mucous membranes. This Phase IIIII clinical trial is designed to understand how well B007 works to achieve remission with minimal treatment and to monitor its safety in this patient population. Participants will receive B007 through subcutaneous injections administered on days 1 and 15. The study measures include the proportion of patients achieving complete remission, partial remission, changes in the Pemphigus Disease Area Index PDAI, frequency of disease relapses, duration of response, and incidence of treatment-emergent adverse events. The treatment period and follow-up assessments extend up to approximately one year. During the trial, participants will be closely monitored through scheduled visits to assess disease activity and treatment response. Outcomes such as remission rates and relapse frequency will be tracked, along with safety evaluations for any adverse effects. The total participation duration includes about one year of observation after treatment initiation to fully capture treatment effects and safety data.

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 calderasib alone or combined with cetuximab to treat people with advanced solid tumors that have the KRAS G12C mutation, excluding colorectal cancer. This study aims to measure how many participants experience tumor shrinkage or disappearance and compare the responses between the two treatments. It is a phase 2, open-label trial focused on treatment safety and tolerability. Participants will receive calderasib orally with no set limit on treatment cycles. Some participants will also receive cetuximab via intravenous infusion every two weeks. Treatment continues until criteria for stopping the study intervention are met. The trial uses a randomized, parallel design to compare the two experimental arms. Throughout the study, participants will be monitored for tumor response, adverse events, and treatment discontinuations related to side effects. Researchers will also assess progression-free survival, duration of response, and overall survival up to about 76 months. The trial lasts until April 2032, with ongoing safety and efficacy evaluations during this period.

Researchers are studying treatments for locally advanced or metastatic colorectal cancer mCRC that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This trial aims to evaluate if adding the targeted therapies calderasib and cetuximab to the standard chemotherapy regimen mFOLFOX6 can provide better outcomes compared to mFOLFOX6 with or without bevacizumab. The study focuses on the safety and tolerability of these combinations and whether they can help people live longer without their cancer growing or spreading. Participants will be assigned to one of two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil every two weeks. The other group will receive mFOLFOX6 chemotherapy with or without bevacizumab every two weeks, based on the investigators decision. Treatments will continue until certain stopping criteria are met. During the study, participants will be monitored for side effects and treatment tolerance, with regular assessments of cancer progression. Researchers will measure outcomes such as dose-limiting toxicities, adverse events, progression-free survival, and overall survival. Quality of life will also be evaluated through questionnaires. The study may last up to several years, with monitoring continuing for safety and effectiveness throughout the treatment period and follow-up.