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The termination of this study does not involve safety issues. The overall safety of KN046 is good, and no new safety signals have been found. The decision to terminate this study was made due to the adjustment of the sponsor's development strategy.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thymic carcinoma | Experimental | enrolled subjects will receive KN046 every 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KN046 | Drug | KN046 5 milligram per kilogram, every 2 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Xiaolong Fu, MD | Shanghai Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34393061 | Derived | Remon J, Girard N, Novello S, de Castro J, Bigay-Game L, Bernabe R, Greillier L, Mosquera J, Cousin S, Juan O, Sampayo M, Besse B. PECATI: A Multicentric, Open-Label, Single-Arm Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab and Lenvatinib in Pretreated B3-Thymoma and Thymic Carcinoma Patients. Clin Lung Cancer. 2022 May;23(3):e243-e246. doi: 10.1016/j.cllc.2021.07.008. Epub 2021 Jul 20. |
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| ID | Term |
|---|---|
| D013945 | Thymoma |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
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subjects enrolled receive KN046
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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 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |