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

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)

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95 participants in 1 patient group

Thymic carcinoma

Experimental group

Description:

enrolled subjects will receive KN046 every 2 weeks.

Treatment:

Drug: KN046