This is a Phase I/II, multicenter, open-label clinical trial with dose escalation/dose expansion/efficacy expansion phases, designed to evaluate the safety/tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of MHB088C in participants with advanced solid tumors
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
515
MHB088C for Injection, an antibody drug-conjugated molecule (ADC) MHB088C will be administered intravenously at a frequency of once every 2 weeks (Q2W) or every 3 week (Q3W).
Beijing Cancer Hospital
Beijing, China
RECRUITINGAdverse event (AE) and Serious adverse event (SAE) (Phase Ia)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: After first administration of study drug until 30 days after last dose of study drug. Through phase Ia completion, an average of 1 year.
Dose limited toxicity (DLT) (Phase Ia)
The DLTs of MHB088C will be determined.
Time frame: Cycle 1 (28 days for subjects receiving a dosing frequency of every 2 weeks, or 21 days for subjects receiving a dosing frequency of every 3 weeks)
Maximum tolerated dose (MTD) (Phase Ia)
The maximum tolerated dose (MTD) of MHB088C will be evaluated on the first cycle.
Time frame: Cycle 1 (28 days for subjects receiving a dosing frequency of every 2 weeks, or 21 days for subjects receiving a dosing frequency of every 3 weeks).
Recommended phase II dose (RP2D) (Phase Ib)
RP2D will be selected upon safety, PK and efficacy data.
Time frame: Through phase Ib completion, an average of 1 year.
Objective response rate (ORR) (phase II)
The ORR is defined as the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR), based on RECIST Version 1.1
Time frame: Approximately 48 months.
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