Phase 1 Study of MST-168 in Participants With Advanced Solid Malignant Tumors
ConditionNeoplams
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMabsoft Therapeutics (Shanghai) Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
MST-168
Biological/VaccineMST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
Treatment groups
420 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: MST-168 initial dose level treatment CohortExperimental treatment 1 intervention
Group B: MST-168 dose level 2 treatment CohortExperimental treatment 1 intervention
Group C: MST-168 dose level 3 treatment CohortExperimental treatment 1 intervention
Group D: MST-168 dose level 4 treatment CohortExperimental treatment 1 intervention
Group E: MST-168 dose level 5 treatment CohortExperimental treatment 1 intervention
Group F: MST-168 dose level 6 treatment CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of dose-limiting toxicities (DLT)
Time frame
Day 1 - Day 282
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 monthsSecondary outcomes
1
PK parameters for MST-168, total anti-drug antibody and free payload: Tmax
Time frame
Day 1 to Day 82
PK parameters for MST-168, total anti-drug antibody and free payload: Cmax
Time frame
Day 1 to Day 83
PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-t
Time frame
Day 1 to Day 84
PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-∞
Time frame
Day 1 to Day 8Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mabsoft Therapeutics (Shanghai) Co., Ltd.
Lead sponsor
Mabsoft Therapeutics (Australia) Pty. Ltd.
Collaborator
Mabsoft Therapeutics (Guangdong Hengqin) Co., Ltd.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: