For Healthcare Professionals

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

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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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria

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

EXCLUSION CRITERIA

Exclusion Criteria

  1. Thymomas, thymolipoma, germ cell tumors, teratomas, seminomas
  2. Leptomeningeal metastasis or untreated active CNS (central nervous system) metastasis or leptomeningeal metastasis.
  3. Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks
  4. Has received other anti-tumor treatment within 4 weeks
  5. Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment
  6. Curative radiation within 3 months of the first dose of trial treatment.
  7. 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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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

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