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 an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB571 Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC).
This is a multicenter, open-label, Phase II clinical study to evaluate the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC). Approximately 150 subjects will be enrolled in this study, including 3 cohorts.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSCLC with sensitive EGFR mutations | Experimental |
| |
| NSCLC with EGFR wild-type | Experimental |
| |
| NSCLC with uncommon EGFR mutations | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKB571 for injection | Drug | Intravenous(IV) infusion(Q3W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Up to approximately 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS), duration of response (DOR), disease control rate (DCR), and overall survival (OS) | Up to approximately 36 months | |
| Safety and tolerability | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (based on CTCAE v6.0), clinically significant abnormal laboratory test results, etc. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between biomarkers and efficacy | To evaluate the correlation between the expression levels of tumor-related genes in tumor tissues and efficacy | Up to approximately 36 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Li, MD | Contact | 86-13311373861 | lixin@kelun.com |
| Name | Affiliation | Role |
|---|---|---|
| Xin Li, MD | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| Xinqiao Hospital of Army Medical University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Osimertinib | Drug | orally once daily |
|
| Furmonertinib | Drug | orally once daily |
|
| carboplatin | Drug | Intravenous(IV) infusion(Q3W) |
|
| Cisplatin | Drug | Intravenous(IV) infusion(Q3W) |
|
| Pembrolizumab | Drug | Intravenous(IV) infusion(Q3W) |
|
| Up to approximately 36 months |
| Maximum Plasma Concentration (Cmax) of SKB571-ADC | Blood Samples will be collected to determine the Cmax of SKB571-ADC in the plasma | Up to approximately 36 months |
| Immunogenicity | Blood Samples will be collected to measure Anti-drug antibody (ADA) against SKB571 in the serum | Up to approximately 36 months |
| Minimum Plasma Concentration(Cmin) of SKB571-ADC | Blood samples will be collected to determine the Cmin of SKB571-ADC in the plasma | Up to approximately 36 months |
| Maximum Plasma Concentration(Cmax) of SKB571-TAb | Blood samples will be collected to determine the Cmax of SKB571-TAb in the plasma | Up to approximately 36 months |
| Minimum Plasma Concentration(Cmin) of SKB571-TAb | Blood Samples will be collected to determine the Cmin of SKB571-TAb in the plasma | Up to approximately 36 months |
| Maximum Plasma Concentration (Cmax) of unconjugated KL610348 | Blood Samples will be collected to determine the Cmax of unconjugated KL610348 in the plasma | Up to approximately 36 months |
| Minimum Plasma Concentration(Cmin) of unconjugated KL610348 | Blood Samples will be collected to determine the Cmin of unconjugated KL610348 in the plasma | Up to approximately 36 months |
| Chongqing |
| Chongqing Municipality |
| 400037 |
| China |
|
| Fujian Provincial Cancer Hospital | Fuzhou | Fujian | 350014 | China |
|
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | 361003 | China |
|
| Dongguan People's Hospital | Dongguan | Guangdong | 523018 | China |
|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
|
| Guangzhou Medical University First Affiliated Hospital | Guangzhou | Guangdong | 510120 | China |
|
| Guilin Medical University First Affiliated Hospital | Guilin | Guangxi | 541001 | China |
|
| Guangxi Medical University Affiliated Tumor Hospital | Nanning | Guangxi | 530021 | China |
|
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150081 | China |
|
| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
|
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Xiangyang Central Hospital | Xiangyang | Hubei | 441021 | China |
|
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
|
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
|
| Jiangxi Cancer Hospital | Nanchang | Jiangxi | 330029 | China |
|
| Jilin Cancer Hospital | Changchun | Jilin | 130012 | China |
|
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110004 | China |
|
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |
|
| Shanxi Cancer Hospital | Taiyuan | Shanxi | 030013 | China |
|
| The First Affiliated Hospital of Xi'an Jiao Tong University | Xi’an | Shanxi | 710061 | China |
|
| Sichuan Cancer Hospital & Institute | Chengdu | Sichuan | 610041 | China |
|
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
|
| Tianjin Cancer Hospital | Tianjin | Tianjin Municipality | 300060 | China |
|
| Xinjiang Medical University Affiliated Tumor Hospital | Ürümqi | Xinjiang Uygur Autonomous Region | 830011 | China |
| Yunnan Cancer Hospital | Kunming | Yunnan | 650118 | China |
|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
|
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007267 | Injections |
| C000596361 | osimertinib |
| C000705711 | aflutinib |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided