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

A

Alphamab

Status and phase

Terminated
Phase 2

Conditions

Thymic Carcinoma

Treatments

Drug: KN046

Study type

Interventional

Funder types

Industry

Identifiers

NCT04469725
KN046-205

Details and patient eligibility

About

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.

Enrollment

95 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

95 participants in 1 patient group

Thymic carcinoma
Experimental group
Description:
enrolled subjects will receive KN046 every 2 weeks.
Treatment:
Drug: KN046

Trial contacts and locations

1

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Central trial contact

Zhonglin Chen

Data sourced from clinicaltrials.gov

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