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This is a multicenter, phase II study. The purpose of this study is to evaluate the safety and preliminary anti-tumor activity of SKB571 in patients with advanced non-small cell lung cancer. Eligible subjects will receive SKB571 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SKB571 monotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKB571 for injection | Drug | SKB571 for injection is administered every 3 weeks(Q3W) until radiographic disease progression,intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| AE | Incidence and severity of adverse events (AEs) | Up to 24 months |
| ORR | Objective response rate (ORR) (assessed by the investigators as per RECIST v1.1) | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors. | Up to 24 months |
| DOR | Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Li | Contact | 086-010-58202512 | lixin@kelun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University Cancer Center | Not yet recruiting | Guangzhou | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Up to 24 months |
| OS | Time from start of treatment to death due to any reason. | Up to 24 months |
| DCR | Disease control rate (DCR) (assessed by the investigators as per RECIST v1.1) | Up to 24 months |
| Henan Cancer Hospital | Recruiting | Zhengzhou | China |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |