Status:
TERMINATED
KN046 (a Humanized PD-L1/CTLA4 Bispecific Single Domain Fc Fusion Protein Antibody) in Subjects With Thymic Carcinoma
Lead Sponsor:
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Conditions:
Thymic Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 progr...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2023
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04469725
Start Date
December 2 2020
End Date
July 7 2023
Last Update
March 12 2024
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030