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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Objective response rate (ORR)
Time frame: Up to approximately 36 months
Progression-free survival (PFS), duration of response (DOR), disease control rate (DCR), and overall survival (OS)
Time frame: 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.
Time frame: 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
Time frame: Up to approximately 36 months
Immunogenicity
Blood Samples will be collected to measure Anti-drug antibody (ADA) against SKB571 in the serum
Time frame: 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
Time frame: 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
Time frame: 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
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Intravenous(IV) infusion(Q3W)
Intravenous(IV) infusion(Q3W)
Intravenous(IV) infusion(Q3W)
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGXinqiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGFujian Provincial Cancer Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
NOT_YET_RECRUITINGDongguan People's Hospital
Dongguan, Guangdong, China
NOT_YET_RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGGuangzhou Medical University First Affiliated Hospital
Guangzhou, Guangdong, China
RECRUITINGGuilin Medical University First Affiliated Hospital
Guilin, Guangxi, China
NOT_YET_RECRUITINGGuangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China
NOT_YET_RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITING...and 17 more locations
Time frame: 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
Time frame: 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
Time frame: Up to approximately 36 months