Ji Nan Shi

Researchers are evaluating the benefit of the 21-gene assay in elderly women aged 65 years and older with Luminal A type breast cancer that has spread to axillary lymph nodes after surgery. This single-center, bidirectional cohort study aims to include 35 such patients to understand the predictive value of this genetic test for patient survival and the potential benefit of chemotherapy. Important clinical and pathological data will be collected, and the study will focus on patients with specific hormone receptor and gene expression profiles, including Luminal A and certain Luminal B subtypes. After patients provide informed consent, their clinical information, surgical records, treatment plans, and actual treatments including chemotherapy, radiotherapy, endocrine therapy, or targeted therapy will be recorded. Paraffin tissue samples from the breast cancer and metastatic lymph nodes will be gathered for the 21-gene assay to calculate recurrence risk using a specialized risk index. Patients will be assessed annually for recurrence and, if recurrence occurs, survival follow-up will be conducted every three months until death. Participants will be followed long-term to monitor recurrence and survival outcomes. The study includes detailed clinical and pathological evaluations, treatment tracking, and genetic testing of tumor tissues. The main outcome measure is whether the 21-gene assay can help predict prognosis and identify which patients may benefit from chemotherapy, with follow-up continuing until patients reach 80 years old or pass away.

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are evaluating the safety, tolerability, and preliminary effectiveness of [225Ac]Ac-FAPI-XT injection in patients who have advanced solid tumors that test positive for fibroblast activation protein (FAP). This Phase 1, single-center, single-arm study focuses on patients who have measurable tumors and have not responded to or cannot tolerate standard treatments. The study also involves assessing the drug's dosimetry to understand how it distributes within the body. Participants will receive doses of [225Ac]Ac-FAPI-XT every six weeks. This treatment is given as an injection and is designed to target advanced tumors expressing FAP. The study does not include a comparison group and focuses on monitoring the effects and safety of this investigational drug over time. During the study, participants will be closely monitored for any adverse events and dose-limiting toxicities for up to two years. Evaluations will include clinical assessments, imaging studies, and laboratory tests to track safety and response to the treatment. The total participation time varies depending on individual treatment schedules and follow-up periods designed to capture long-term effects and tolerability.

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 years. This randomized, double-blind, placebo-controlled study involves single-dose administration, dose escalation, and an expansion phase. The study aims to understand how the body processes AK0610 and monitor any adverse effects that may arise. The study has two parts: the dose-escalation phase and the expansion phase. In the dose-escalation phase, five groups of 8 participants each receive increasing doses of AK0610 or placebo via intramuscular or intravenous injection. Based on pharmacokinetic data, two additional larger groups of 48 participants each will receive specific doses in the expansion phase. Participants undergo a screening period before dosing, followed by inpatient observation and a blinded follow-up period. Those receiving AK0610 will also participate in an open-label period extending up to 361 days. Participants will be assessed through physical exams, safety monitoring, and pharmacokinetic tests throughout the study. Researchers will track the incidence and severity of any treatment-emergent adverse events up to 361 days. The study includes detailed observation during inpatient and follow-up periods to ensure participant safety and collect necessary data on the drug's effects over time.

Researchers are evaluating the safety and effectiveness of a drug called B001 injection in patients who have neuromyelitis optica spectrum disorder (NMOSD) and test positive for aquaporin-4 antibodies. This study is a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial designed to compare B001 with a placebo in this patient population. The goal is to assess whether B001 can reduce the time to the first NMOSD attack during the study period. Participants will receive either an intravenous dose of B001 or a matching placebo on Day 1 and Day 15 during the randomized controlled period (RCP). Both treatment groups follow the same dosing schedule to evaluate the effects of B001 compared to placebo over approximately 48 weeks. During the study, participants will be closely monitored through regular assessments to track any NMOSD attacks and overall health. Researchers will measure the time to the first NMOSD attack as the primary outcome. Safety and any side effects of the treatment will also be evaluated throughout the study period. Participants are expected to complete all required tests and follow study procedures as part of their involvement.

Researchers are evaluating the effectiveness and safety of a drug called B007 in people with generalized myasthenia gravis, a condition that affects muscle strength. This study is a Phase II/III clinical trial designed to compare B007 with a placebo to better understand its impact on daily living activities in affected patients. Participants receive either a high or low dose of B007 or a matching placebo, both given as subcutaneous injections on days 1 and 15. The study includes two groups: those treated with B007 and those given placebo, with treatment administered twice during the trial period. During the study, participants will be monitored for changes in their myasthenia gravis activities of daily living profile (MG-ADL). The main outcome measured is the proportion of participants whose MG-ADL score decreases by 2 or more after approximately 16 weeks. Safety and adherence are also tracked throughout the study.

Researchers are evaluating the safety and effectiveness of B007 in adult subjects diagnosed with pemphigus, a condition characterized by specific clinical signs. This Phase II/III clinical study aims to determine how well B007 works in treating this disease, including those newly diagnosed or experiencing a relapse. Participants receive B007 through subcutaneous injections given on day 1 and day 15. The study includes varying doses of B007 to assess treatment outcomes over time. This controlled dosing schedule allows researchers to monitor responses to the medication closely. During the study, researchers will track the proportion of subjects who achieve complete remission with minimal treatment by approximately 36 weeks. Participants are expected to follow the study protocol, which includes regular assessments to monitor treatment effects and safety. Long-term monitoring will help determine the success of B007 in managing pemphigus symptoms.

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 studying whether calderasib alone or combined with cetuximab can treat advanced solid tumors in people who have the KRAS G12C mutation. This phase 2, open-label trial aims to find out how many participants respond to these treatments and to compare their safety and tolerability. Participants receive calderasib by mouth and cetuximab through intravenous infusion. The study includes people with locally advanced or metastatic solid tumors other than colorectal cancer, who have already undergone standard treatments. The trial monitors response and side effects over time as participants receive either calderasib alone or in combination with cetuximab. During the study, participants undergo regular assessments to measure tumor response and track any side effects or adverse events. Researchers record how many people experience treatment-related side effects and how many stop treatment due to these effects. The study follows participants for up to approximately 76 months to assess long-term outcomes and safety.

Researchers are evaluating new treatment options for adults with locally advanced or metastatic colorectal cancer that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This study compares the safety and effectiveness of adding calderasib and cetuximab, both targeted therapies, to a standard chemotherapy regimen called mFOLFOX6. The goal is to see if this combination can help patients live longer without their cancer growing or spreading compared to current treatments that may include mFOLFOX6 with or without bevacizumab. The study has two parts. It involves treatment with calderasib taken as an oral tablet, cetuximab given according to standard procedures, and mFOLFOX6 chemotherapy combining oxaliplatin, leucovorin/levofolinate calcium, and 5-fluorouracil. Some participants may receive bevacizumab or a bevacizumab biosimilar as part of the comparison. The treatments are given following approved dosing schedules. This design allows researchers to assess the safety and tolerability of these drug combinations in treating this type of colorectal cancer with the KRAS G12C mutation. Participants will be monitored for side effects, treatment tolerability, and cancer progression over a period that may last up to about 44 months. Researchers will track outcomes such as how many participants experience dose-limiting toxicities or adverse events, how many stop treatment due to side effects, and progression-free survival time. Assessments include health evaluations, laboratory tests, and imaging to observe cancer status. This long-term follow-up aims to understand both safety and effectiveness of the treatment combinations.