KN046 (a Humanized PD-L1/CTLA4 Bispecific Single Domain Fc Fusion Protein Antibody) in Subjects With Thymic Carcinoma

A Phase 2, Open-Label, Multi-Center Study to Evaluate Efficacy, Safety and Tolerability of KN046 in Subjects With Thymic Carcinoma

This is a Phase 2, open-label, multi-center, single arm study in subjects with advanced thymic carcinoma after failure of platinum-based combination chemotherapy. Subjects should have documented progressive disease while on platinum-based combination chemotherapy. If subjects discontinued platinum-based therapy due to reasons other than progressive disease, subjects should have completed at least 2 cycles of platinum-based combination chemotherapy before the commencement of documented progressive disease. Subjects will be treated with KN046 5 milligram per kilogram every 2 weeks.

Inclusion Criteria

• Male or female, ≥18 years
• Pathologically confirmed diagnosis of thymic carcinoma
• Inoperable or metastatic disease
• Had failed at least one regimen containing platinum-based combination chemotherapy for locally advanced unresectable or metastatic disease
• Baseline measurable disease

Exclusion Criteria

• Thymomas, thymolipoma, germ cell tumors, teratomas, seminomas
• Leptomeningeal metastasis or untreated active CNS (central nervous system) metastasis or leptomeningeal metastasis.
• Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks
• Has received other anti-tumor treatment within 4 weeks
• Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment
• Curative radiation within 3 months of the first dose of trial treatment.
• Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment