This is a single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety, tolerability and preliminary efficacy of 9MW3811 in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Intravenous injection
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Incidence of adverse events (AEs) as assessed by CTCAE v5.0
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: up to 24 weeks
Incidence of dose-limiting toxicity (DLT) as assessed by CTCAE v5.0
A DLT is defined as any of the adverse drug reactions listed in the protocol that will be assessed during Cycle 1
Time frame: Cycle 1 Day 1 to Cycle 1 Day 21
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators
To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Time frame: up to 24 weeks
Disease Control Rate (DCR), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators
To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Time frame: up to 24 weeks
Duration of Response (DoR), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators
To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Time frame: up to 24 weeks
Progression Free Survival (PFS), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators
To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
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Time frame: up to 24 weeks
Maximum Plasma Concentration (Cmax)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Time frame: up to 24 weeks
Time to reach Cmax (Tmax)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Time frame: up to 24 weeks
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Time frame: up to 24 weeks
Terminal elimination half-life (t1/2)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Time frame: up to 24 weeks
AUC from time 0 extrapolated to infinity (AUC0-inf)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Time frame: up to 24 weeks
Terminal elimination rate constant (λz)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Time frame: up to 24 weeks
Apparent clearance (CL)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Time frame: up to 24 weeks
Volume of distribution (Vz)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Time frame: up to 24 weeks
Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline
To determine the immunogenicity of 9MW3811.
Time frame: up to 24 weeks