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This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB518 in patients with lung cancer. Eligible subjects will receive SKB518 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 |
|---|---|---|---|
| 2L+ SCLC or non-Squamous NSCLC | Experimental | SKB518 monotherapy |
|
| 2L SCLC | Experimental | SKB518+Tislelizumab or Tislelizumab monotherapy |
|
| 1L ES-SCLC | Experimental | SKB518+Tislelizumab+Carboplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKB518 | Drug | SKB518 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 in specific arms | Objective Response Rate (ORR) assessed by the investigators per RECIST v1.1 | Up to 24 months |
| PFS in specific arm | Progression-Free Survival (PFS) assessed by the investigators per RECIST v1.1 | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS in specific arms | Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors. | Up to 24 months |
| DOR in specific arms | 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 |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center | Recruiting | Shenzhen | Guangdong | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| Tislelizumab | Drug | Tislelizumab is administered every 3 weeks(200 mg, Q3W) until radiographic disease progression, intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first. |
|
|
| Carboplatin | Drug | Carboplatin is administered at every 3 weeks(AUC 5 mg/mL/min, Q3W) for 4 cycles |
|
| Up to 24 months |
| OS | Time from start of treatment to death due to any reason. | Up to 24 months |
| Pharmacokinetics | Maximum and minimum drug concentrations (Cmax and Cmin) of SKB518-ADC and SKB518-TAb (antibody-drug conjugate and total antibody forms of SKB518) in Serum; Cmax and Cmin of SKB518-Free Payload in Plasma | Up to 24 months |
| Immunogenicity | Anti-Drug Antibody(ADA) Titre of SKB518 | Up to 24 months |
| Cancer Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | China |
|
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | China |
|
| Hubei Cancer Hospital | Recruiting | Wuhan | Hubei | China |
|
| Renmin Hospital of Wuhan University | Recruiting | Wuhan | Hubei | China |
|
| Xiangyang Central Hospital | Recruiting | Xiangyang | Hubei | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | China |
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| Jiangxi Cancer Hospital | Recruiting | Nanchang | Jiangxi | China |
|
| Cancer Hospital of Shandong First Medical University | Recruiting | Jinan | Shandong | China |
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| Shanxi Cancer Hospital | Recruiting | Taiyuan | Shanxi | China |
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| Affiliated Cancer Hospital of Xinjiang Medical University | Recruiting | Ürümqi | Xinjiang | China |
|
| Yunnan Cancer Hospital | Recruiting | Kunming | Yunnan | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | China |
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| Taizhou Hospital of Zhejiang Province | Recruiting | Taizhou | Zhejiang | China |
|
| Cancer Hospital Chinese Academy of Medical Science | Recruiting | Beijing | China |
|
| Shanghai Pulmonary Hospital (Affiliated to Tongji University) | Recruiting | Shanghai | China |
|
| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | China |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |