Tangshan

Researchers are evaluating ATG-022 in patients with advanced or metastatic solid tumors in this Phase I, multi-center, open-label clinical trial. The study aims to find the best dose of ATG-022 and to assess its safety and how well it is tolerated. The trial includes patients whose tumors have progressed despite standard treatments or who cannot undergo standard therapies, with a focus on solid tumors and those expressing Claudin 18.2 in the Dose Expansion Phase. The study consists of two main parts a Dose Escalation Phase and a Dose Expansion Phase. In the Dose Escalation Phase, patients receive ATG-022 in cycles of 21 days, starting with a low dose of 0.3 mgkg every three weeks, increasing through defined dose levels to find the maximum tolerated dose. The Dose Expansion Phase enrolls up to 120 patients with Claudin 18.2-positive tumors at the recommended dose to further evaluate safety and efficacy. Participants will undergo biopsies if recent tumor samples are unavailable and must have measurable tumors per RECIST v1.1 criteria. Researchers will monitor side effects and dose-limiting toxicities within 21 days and assess progression-free survival, overall response rate, and duration of response up to 12 months after the last patient is enrolled. Women of childbearing potential and men must use contraception during and after the study. The total participation time varies depending on treatment and follow-up schedules.

Researchers are evaluating AK104, an anti-PD-1 and CTLA-4 bispecific antibody, alone or combined with chemotherapy, for adults with recurrent or metastatic vulvar cancer that cannot be cured with surgery or radiotherapy. This phase II, open-label study aims to assess the treatments effectiveness and safety in this specific group of patients. Participants receive either AK104 alone at 15 mgkg intravenously every 3 weeks until disease progression, unacceptable side effects, completion of 2 years of treatment, or withdrawal, or a combination of AK104 at 10 mgkg plus chemotherapy drugs paclitaxel and cisplatin or carboplatin intravenously every 3 weeks for up to 6 cycles. After chemotherapy, patients continue maintenance therapy with AK104 10 mgkg every 3 weeks under the same stopping conditions. During the study, participants will undergo regular assessments including tumor measurements to evaluate response, monitoring for side effects, and blood tests to measure drug levels and antibodies. The primary outcome is the objective response rate measured up to about 1 year. Secondary outcomes include progression-free survival, duration of response, disease control rate, time to response, overall survival, adverse events, and drug-related antibody monitoring for up to about 2 years. The total participation period varies based on treatment duration and follow-up.

Researchers are evaluating benralizumab in patients aged 12 years and older with severe eosinophilic asthma to better understand its clinical profile and how well it works in a real-world setting in China. The study aims to observe early treatment responses, treatment outcomes, and changes in asthma control. It also looks at reasons why doctors may stop or switch benralizumab therapy. Participants receive benralizumab as prescribed by their clinician without any additional intervention from the study, as this is a non-interventional observational trial. The study collects data over time, focusing on asthma control and lung function. There is only one group of patients receiving benralizumab, and treatment decisions are made by healthcare providers as usual. Participants will be followed and monitored with asthma control questionnaires at weeks 1, 2, 4, 8, 16, 24, 40, and 56. Lung function changes will also be evaluated at weeks 8, 16, and 56. The primary outcome is asthma control at week 8. Data collection will continue until the study ends in January 2028, providing insights into treatment effects and patient experiences in routine care.