Tangshan

Researchers are conducting a Phase I, multi-center, open-label study to evaluate ATG-022 in patients with advanced or metastatic solid tumors. The study includes patients whose tumors have progressed despite standard treatments, or who are intolerant or not suitable for standard therapies. It aims to find the best tolerated dose and further assess safety, tolerability, and efficacy, especially in tumors expressing Claudin 18.2. The study has two parts: a Dose Escalation Phase and a Dose Expansion Phase. In the Dose Escalation Phase, patients receive increasing doses of ATG-022 every 21 days, starting at 0.3 mg/kg and increasing through defined dose levels using a "3+3" design. The Dose Expansion Phase will treat patients with Claudin 18.2-positive tumors at the maximum tolerated or recommended Phase II dose to gather more safety and effectiveness data. Participants will be closely monitored through tumor biopsies, imaging assessments using RECIST v1.1 criteria, and safety evaluations throughout the study. Life expectancy of at least 12 weeks and good performance status are required. The primary outcomes include determining dose-limiting toxicities, maximum tolerated dose, and recommended Phase II dose within 21 days. Contraception use and pregnancy testing are part of participant requirements to ensure safety.

Researchers are evaluating the effectiveness and safety of AK104, an antibody targeting PD-1 and CTLA-4, in women with recurrent or metastatic vulvar cancer that cannot be cured with surgery or radiotherapy. This is a multicenter, open-label phase II study focusing on this specific type of vulvar cancer, including squamous cell carcinoma and adenosquamous carcinoma. Participants must meet certain health and tumor criteria to join the study. The study has two treatment groups. One group receives AK104 alone at a dose of 15 mg/kg intravenously every three weeks for up to two years, or until disease progression or unacceptable side effects occur. The other group receives a combination of AK104 (10 mg/kg) with chemotherapy drugs paclitaxel and either cisplatin or carboplatin every three weeks for up to six cycles, followed by maintenance therapy with AK104 alone at 10 mg/kg every three weeks under the same conditions. Participants will undergo regular assessments including tumor measurements based on RECIST v1.1 criteria and laboratory tests to monitor organ function. The primary outcome measured is the objective response rate assessed by investigators for up to approximately one year. Safety monitoring will continue throughout treatment and until two years or withdrawal. Female participants of childbearing potential must have a negative pregnancy test before starting and agree to use effective contraception during the study.