Treatment of Advanced and Metastatic Solid Tumors With MIL97
Status:
Not yet recruiting
Trial end date:
2024-01-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1, global, multi-center, open-label, multiple-dose, first-in-human study of
MIL97 to evaluate the safety, tolerability, pharmacokinetics, biomarkers and efficacy in
subjects with advanced or metastatic solid tumor. The study consists of a dose escalation
phase and a dose expansion phase. An accelerated titration design (cohorts 1-2 only) followed
by 3+3 dose-escalation design will be used in dose escalation phase.
The starting dose for dose escalation phase is 0.01 mg/kg Q3W, followed by 5 dose cohorts
(0.03mg/kg Q3W, 0.1mg/kg Q3W, 0.2mg/kg Q3W, 0.3mg/kg Q3W and 0.45mg/kg Q3W). Duration of dose
limiting toxicity (DLT) observation is 21 days. Based on data of 3-week treatment regimen,
one or two dose levels may be chosen for Q2w regimen. Duration of dose limiting toxicity
(DLT) observation is 28 days.
One or two dose cohorts will be chosen (either 2-week regimen or 3-week regimen cohorts) to
expand to total of 10 subjects in each cohort for further exploration of PK as well as safety
and efficacy.