A Single-arm, Open, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of KC1036 in the Patients With Advanced Recurrent or Metastatic Thymic Tumors

KC1036-II-02

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.

2023-02-22

2025-02-01

2026-02-01

Recruiting

Early phase I

30

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 or imaging shows a risk of CNS metastasis; * Previous (within the last 5 years) or current malignancies at other sites; * Gastrointestinal abnormalities; * Cardiovascular and cerebrovascular diseases; * Patients who have previous treatment with small molecule VEGFR-TKI (except patients whose treatment cycle is less than 2 weeks due to intolerance or other reasons); Patients who have previous treatment with PD-1 / PD-L1 antibody combined with small molecule VEGFR-TKI; * Involved in other clinical trials within 4 weeks before enrollment; Prior anti-tumor therapies with chemotherapy, cytotherapy, immunotherapy, operation (Interventional therapy excepted) within 4 weeks 4 weeks before enrollment; Prior radiotherapy (palliative radiotherapy excepted) within 2 weeks; Prior small-molecule targeted therapy within 2 weeks or 5 half-lives. * Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE V5.0 grade 0 or 1 with the exception of alopecia; * Skin wound, surgical site, wound site, mucous membrane severe ulcer or fracture comfirmed as having not recovered; * Uncontrolled mass pleural effusion, ascites, and pericardial effusion; * Active autoimmune diseases: Myasthenia gravis, pure red cell aplastic anemia, systemic lupus erythematosus, inflammatory bowel disease, etc; * Need immunosuppressive agents or hormone therapy for immunosuppression, , and still need immunosuppressive therapy within 2 weeks before enrollment; * Active bacterial, viral or fungal infection; Fever of unknown cause (\> 38.5℃) occurred within 2 weeks before enrollment; * Patients who are positive for both Hepatitis B surface antigen (HBsAg) and hepatitis B virus deoxyribonucleic acid (HBV-DNA) quantification results; Patients who are positive for both hepatitis C virus antibody (HCAB) and hepatitis C virusribonucleic acid (HCV-RNA) quantification results; Patients who are positive for human immunodeficiency virus (HIV); * Pregnant or lactating women; * Patients who do not take contraception during the study period and within 6 months after the study; * Patients with insufficient compliance as evaluated by investigator; * The investigator believes that it is not suitable to patient in this clinical trial.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2023-03-09