The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB264 in combination with KL-A167 with or without chemotherapy with advanced or metastatic non-small cell lung cancer. The study is divided into two parts. Part 1 will be the safety run-in phase, and Part 2 will be the cohort expansion phase.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
SKB264 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (5mg/kg)
KL-A167 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (1200mg Q3W)
Carboplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle(AUC 5)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, China
RECRUITINGIncidence and severity of adverse events (AEs)
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: From baseline up to 30 days after last dose or to the beginning of the new anti-cancer therapy, up to 24 months
Objective Response Rate (ORR)
Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Investigator based on RECIST version 1.1.
Time frame: From baseline to first documented objective response, up to 24 months
Progression-free survival (PFS)
Progression-free survival (PFS) was defined as the time from baseline to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions.
Time frame: From baseline to the first documented disease progression or date of death (whichever occurs first), up to 24 months
Duration of response (DOR)
Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR was measured for responding subjects (PR or CR) only.
Time frame: From the date of first objective response (CR or PR) to the date of first documentation of PD or death (whichever occurs first), up to 24 months
Disease control rate (DCR)
Disease control rate (DCR) was defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate. As per RECIST v1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
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Cisplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (75mg/m²)
Time frame: From baseline to date of first documented objective response (CR, PR, and SD), up to 24 months
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of SKB264-ADC, SKB264-TAB and free KL610023
Time frame: Cycle 1-8, every 4 cycles starting from Cycle 12 Day 1: pre-dose, post-dose (each cycle is 21 days), up to 24 months
Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) of SKB264-ADC, SKB264-TAB and free KL610023
Time frame: Cycle 1-8, every 4 cycles starting from Cycle 12 Day 1: pre-dose, post-dose (each cycle is 21 days), up to 24 months
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of KL-A167
Time frame: Cycle 1-8, every 4 cycles starting from Cycle 12 Day 1: pre-dose, post-dose (each cycle is 21 days), up to 24 months
Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) of KL-A167
Time frame: Cycle 1-8, every 4 cycles starting from Cycle 12 Day 1: pre-dose, post-dose (each cycle is 21 days), up to 24 months
Anti-drug Antibodies (ADA) for SKB264 and KL-A167
Time frame: Cycle 1-8, every 4 cycles starting from Cycle 12 Day 1: pre-dose, post-dose (each cycle is 21 days), up to 24 months