KN046 (a Humanized PD-L1/CTLA4 Bispecific Single Domain Fc Fusion Protein Antibody) in Subjects With Thymic Carcinoma
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Thymic Carcinoma
Age (in years)
18+
Phase
Phase 2
Participants needed
66
Est. Completion Date
Aug 31, 2025
Treatment type
Interventional
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
ClinicalTrials.gov identifier
NCT04469725
Study number
KN046-205
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?