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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Open-Label, Multi-Center Study to Evaluate Efficacy, Safety and Tolerability of KN046 in Subjects With Thymic Carcinoma

Conditions
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Thymic Carcinoma

Intervention / Treatment
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* Drug: KN046


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: subjects enrolled receive KN046
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thymic carcinoma<br>enrolled subjects will receive KN046 every 2 weeks. | Drug: KN046<br>* KN046 5 milligram per kilogram, every 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | ORR (best overall response) per RECIST v1.1 calculated as the proportion of subjects with a best overall response defined as confirmed complete response or confirmed partial response (CR+PR) by Independent Review Committee; | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DOR | DOR (duration of response), calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer; | up to 3 years | 
| DCR | DCR (disease control rate), calculated as the proportion of subjects with best overall response of CR, PR, or SD (stable disease); | up to 3 years | 
| CBR | CBR (clinical benefit rate), calculated as the proportion of subjects with best overall response of CR, PR, or SD on at least 24 weeks; | up to 3 years | 
| PFS | PFS (progression free survival), defined as time from first dose of trial treatment to progression or death due to any cause; | up to 3 years | 
| TTR | TTR (time to response), calculated as the time from first dose of trial treatment to first documented response (CR+PR); | up to 3 years |