This is a first-in-human (FIH), phase 1, multicenter, open-label, dose-escalation study of SKB518 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor relapsed/refractory to standard therapies or for which no effective standard therapy is available.
This is a first-in-human (FIH), phase 1, multicenter, open-label, dose-escalation study of SKB518 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor relapsed/refractory to standard therapies or for which no effective standard therapy is available. Dose escalation and de-escalation decisions are based on the mTPI-2 design and depend on the number of subjects enrolled and the number of DLTs observed at the current dose level.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
SKB518 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.
Fudan University Shanghai Cancer Center
Shanghai, China, China
RECRUITINGNumber of subjects achieving Dose-limiting toxicity (DLT)
DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.
Time frame: From data of initial dose until up to 21 days for treatment
Maximum Tolerated Dose (MTD)
Once the dose escalation stopping criteria are met, the MTD estimated by mTPI-2 will be the dose at which the probability of posterior mean of the DLT rate is between 25% and 35%, closest to 30%, and no more than 35%.
Time frame: From data of initial dose until up to 21 days for treatment
Objective Response Rate (ORR)
The sum of the number of cases with Complete Response (CR) and Partial Response (PR) in all treated tumor patients (CR + PR) divided by the total number of cases.
Time frame: Up to 24 months
Progression Free Survival (PFS)
Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
Time frame: Up to 24 months
Duration of Response (DOR)
Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
Time frame: Up to 24 months
Overall Survival (OS)
Time from start of treatment to death due to any reason.
Time frame: Up to 24 months
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