Treatment of Advanced and Metastatic Solid Tumors With MIL97
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Adult patients, \>=18 years of age; 2. Diagnosis of Refractory/relapsed metastatic and/or unresectable solid tumors; 3. At least one extracranial measurable unirradiated lesion or evaluable lesion (recist v1.1) ; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Life expectancy \>=3 months; 5. Sufficient organ and bone marrow function within 7 days before enrollment; 6. Life expectancy \>=12 weeks; 7. Able and willing to provide written informed consent and to comply with the study protocol. Exclusion Criteria: 1. have a history of myocardial infarction within 6 months or a history of arterial thromboembolic event within 3 months before the first dose; 2. Comorbidity that would interfere with therapy, including interstitial pneumonia, symptomatic congestive heart failure; unstable angina, uncontrolled hypertension; ongoing cardiac arrhythmia ≥ CTCAE 5.0 Grade 3, active coagulopathy, uncontrolled diabetes, QTcF\>450ms (Male) or QTcF\>470ms (