Phase II Study to Test the Safety and Effectiveness of KC1036 in Adults with Advanced or Recurrent Thymic Tumors

What this Trial Is About

Researchers are evaluating the safety and effectiveness of KC1036 in patients with advanced recurrent or metastatic thymoma or thymic carcinoma, which are rare types of thoracic tumors. This phase II, open-label, single-arm study aims to address the urgent need for effective treatments in patients who have not benefited from first-line chemotherapy. Previous phase I studies showed promising results for KC1036, supporting further investigation. Participants will take 60 mg of KC1036 orally once daily in 21-day treatment cycles. Safety assessments will occur every 21 days, and tumor responses will be evaluated every two cycles. Treatment continues until the disease progresses, unacceptable side effects occur, or the patient chooses to stop. This multicenter study is sponsored by Beijing Konruns Pharmaceutical Co., Ltd. During the study, participants will undergo regular evaluations including tumor imaging to measure response and safety monitoring over approximately two years. Researchers will assess outcomes such as objective response rate, progression-free survival, disease control rate, duration of response, and adverse events. The study includes adults aged 18 to 75 with confirmed thymic tumors and measurable lesions, requiring ongoing monitoring throughout participation.

A Study of KC1036 in Patients with Advanced Thymic Tumors