The purpose of this study is to assess the safety and efficacy of SKB264 monotherapy in subjects with selected advanced solid tumors.The study is divided into two parts: the Part Ⅰ consists of 5 cohorts, and the Part Ⅱ for expansion. Eligible subjects will receive SKB264 monotherapy, until there is no longer clinical benefit, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
The second part of this study is a randomized, open-label, multicenter Phase 2 clinical study of SKB264 monotherapy versus docetaxel in subjects with locally advanced or metastatic non-squamous NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
321
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR) as the best overall response assessed per RECIST 1.1.
Time frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 21 months.
Incidence 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 subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment.
Progression-free survival (PFS)
PFS is defined as the time from the first dose to progressive disease (PD) or death, whichever occurs first. PD will be assessed per RECIST 1.1.
Time frame: From baseline until disease progression, death, or other protocol defined reason,up to approximately 21 months.
Duration of response (DOR)
DOR is defined as the time from the date of first documented CR or PR to PD or death due to any cause, whichever occurs first.
Time frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 21 months.
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR or stable disease (SD) as the best overall response assessed per RECIST 1.1.
Time frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 21 months.
Overall survival (OS)
OS is defined as the time period from the start of administration to death due to any cause.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From baseline until death due to any cause.
Immunogenicity
Presence of Anti-drug antibodys (ADAs) for SKB264.
Time frame: From baseline up to 12 months after last patient enrollment.
PK
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of SKB264-ADC, SKB264-TAB and free KL610023.
Time frame: From baseline up to 12 months after last patient enrollment.
PK
Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) of SKB264-ADC, SKB264-TAB and free KL610023.
Time frame: From baseline up to 12 months after last patient enrollment.