Study of Sacituzumab Tirumotecan to Treat Advanced or Metastatic Thymic Carcinoma After Chemotherapy

What this Trial Is About

Researchers are evaluating the drug Sacituzumab tirumotecan Sac-TMT for treating adults with locally advanced or metastatic thymic carcinoma that has progressed after at least one platinum-based chemotherapy. This phase II study aims to determine how well Sac-TMT works and to learn about the safety and adverse effects experienced by participants. The study is sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. and focuses on patients not suitable for curative therapy. Participants will receive Sac-TMT injections every two weeks at a dose of 5 mgkg. Tumor response will be assessed every six weeks to monitor treatment effect. The treatment period extends up to 24 months or until disease progression or discontinuation. There is only one treatment group in this single-group study, with no placebo or comparison group. During the study, participants will undergo tumor tissue sampling and have measurable lesions evaluated using RECIST v1.1 criteria. Researchers will monitor overall response rate, progression-free survival, overall survival, disease control rate, and safety outcomes including adverse events and laboratory abnormalities. The study includes adults aged 18 to 75 years with adequate organ function and expected survival of at least 12 weeks. Participant involvement may last up to 24 months from enrollment through treatment and follow-up assessments.

Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma