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

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    66
  • sponsor
    Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Updated on 26 January 2021

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 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.

Details
Condition Thymoma, Thymomas, thymic carcinoma
Treatment KN046
Clinical Study IdentifierNCT04469725
SponsorJiangsu Alphamab Biopharmaceuticals Co., Ltd
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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