Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase Ia/Ib, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN046 in subjects with advanced solid tumors and lymphoma .
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KN046 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KN046 | Drug | Phase Ia:Intravenous (IV) infusions, 1,3 and 5 milligrams per kilogram (mg/kg) every 2 weeks. Phase Ib:Intravenous (IV) infusions, 1 ,3 or 3, 5 milligrams per kilogram (mg/kg) every 2 weeks, the dose of phase Ib based on the result of phase Ia. |
| Measure | Description | Time Frame |
|---|---|---|
| In the dose escalation part, number of participants with dose limiting toxicity (DLT). | During the first 4 weeks of treatment. | |
| In the dose expansion part,Objective response rate (ORR). | Objective response is defined as complete response (CR) or partial response (PR) | up to 2 years. |
| In the dose expansion part, Duration of response (DoR). | Duration of response is defined as the time period from the date of initial independent review committee assessed CR or PR until the date of PD or death from any cause, whichever occurs first. | up to 2 years. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Fuzhou | Fujian | China | |||
| Fujian Medical University Union Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37263673 | Derived | Ma Y, Xue J, Zhao Y, Zhang Y, Huang Y, Yang Y, Fang W, Guo Y, Li Q, Ge X, Sun J, Zhang B, Zhang Y, Xiao J, Zhang L, Zhao H. Phase I trial of KN046, a novel bispecific antibody targeting PD-L1 and CTLA-4 in patients with advanced solid tumors. J Immunother Cancer. 2023 Jun;11(6):e006654. doi: 10.1136/jitc-2022-006654. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fuzhou |
| Fujian |
| China |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China |
| Henan Cancer Hospital | Zhengzhou | Henan | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
| LINYI Cancer Hospital | Linyi | Shandong | China |
| Shanghai East Hospital | Shanghai | Shanghai Municipality | China |
| Chengdu Seventh People's Hospital | Chengdu | Sichuan | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |