NCT05683886 A Study of KC1036 in Patients with Advanced Thymic Tumors
| NCT ID | NCT05683886 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Beijing Konruns Pharmaceutical Co., Ltd. |
| Condition | Thymic Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-02-22 |
| Primary Completion | 2025-02 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a single arm，open-label, multicentric, phase II study to evaluate the efficacy and safety of KC1036 in patients with advanced recurrent or metastatic thymoma or thymic carcinoma.
Eligibility Criteria
Inclusion Criteria: * Patients with thymoma or thymic carcinoma confirmed by cytologically or histologically (WHO Classification of Thoracic Tumors 5th ed), including all pathological subtypes; * Patients with advanced recurrent, unresectable and/or metastatic thymic tumor as defined by the Masaoka-Koga stage; * Subsequent relapse of disease following first-line systemic chemotherapy; * Patients with at least one measurable lesion as defined by RECIST V1.1; Measurable lesions located within the radiation field of previous radiotherapy or after local treatment can also be selected as target lesions if progression is confirmed. * Eastern Cooperative Oncology Group performance status score of 0 or 1; * Life expectancy \> 12 weeks; * Adequate organ and marrow function; * Patients should participate in the study voluntarily and sign informed consent. Exclusion Criteria: * Patients with thymus neuroendocrine tumors; * Any patient who is known to have central nervous system (CNS) metastasis o