A Phase 1, multiregional, open-label study of MST-168 in participants with target-driven advanced solid tumors. The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic effects, and preliminary efficacy of MST-168 in participants with target-driven advanced solid tumors. MST-168 is an investigational ADC.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
420
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
Incidence of dose-limiting toxicities (DLT)
Time frame: Day 1 - Day 28
Incidence and severity of AEs, clinically significant changes from Baseline (pre-dose on D1) through to the EOT in vital signs, laboratory tests, physical examinations, 12-lead ECG, and ECHO/MUGA.
Time frame: Through study completion, up to 25 months
PK parameters for MST-168, total anti-drug antibody and free payload: Tmax
Time frame: Day 1 to Day 8
PK parameters for MST-168, total anti-drug antibody and free payload: Cmax
Time frame: Day 1 to Day 8
PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-t
Time frame: Day 1 to Day 8
PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-∞
Time frame: Day 1 to Day 8
PK parameters for MST-168, total anti-drug antibody and free payload: t1/2
Time frame: Day 1 to Day 8
PK parameters for MST-168, total anti-drug antibody and free payload: CL
Time frame: Day 1 to Day 8
PK parameters for MST-168, total anti-drug antibody and free payload: Vss
Time frame: Through study completion, up to 24 months
PK parameters for MST-168, total anti-drug antibody and free payload: AUCss
Time frame: Through study completion, up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PK parameters for MST-168, total anti-drug antibody and free payload: Css,max
Time frame: Through study completion, up to 24 months
PK parameters for MST-168, total anti-drug antibody and free payload: Css,min
Time frame: Through study completion, up to 24 months
Frequencies of ADAs and neutralizing antibodies specific to MST-168.
Time frame: Through study completion, up to 24 months
Biomarkers: cytokines/chemokines and immune cell phenotypes
Time frame: Through study completion, up to 24 months
Objective response rate (ORR) based on RECIST v1.1.
Time frame: Through study completion, up to 24 months
Duration of response (DoR) based on RECIST v1.1.
Time frame: Through study completion, up to 24 months
Progression-free survival (PFS) based on RECIST v1.1.
Time frame: Through study completion, up to 24 months
Disease control rate (DCR) based on RECIST v1.1.
Time frame: Through study completion, up to 24 months