Treatment of Advanced and Metastatic Solid Tumors With MIL97
ConditionAdvanced or Metastatic Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Mabworks Biotech Co., Ltd.
About this trial
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
This trial does not accept healthy volunteersQualifiers
Adult patients, >=18 years of age;
Diagnosis of Refractory/relapsed metastatic and/or unresectable solid tumors;
At least one extracranial measurable unirradiated lesion or evaluable lesion (recist v1.1) ;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Life expectancy >=3 months;
Disqualifiers
have a history of myocardial infarction within 6 months or a history of arterial thromboembolic event within 3 months before the first dose;
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 (Female) at screening;
Patients have a known or suspected history of an autoimmune disorder, except for the following: Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders such as vitiligo, or alopecia not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger are eligible;
Have a history of manifested central nervous system (CNS) metastases or have primary brain tumor. Patients with known or suspected leptomeningeal disease or cord compression;
Trial design
Design model
Sequential
Treatments tested in this trial
Recombinant Humanized Monoclonal Antibody MIL97 for Injection
DrugDose escalation phase: The patients confirming to the eligibility criteria will be assigned to the 6 dose groups (0.01mg/kg, 0.03mg/kg, 0.1mg/kg, 0.2mg/kg, 0.3mg/kg 0.45mg/kg, respectively) based on the sequence of inclusion. Each patient will receive an intravenous infusion of MIL97 every 3 week on Day 1 of each cycle. Additional 1 or 2 dose cohorts will receive an intravenous infusion of MIL97 every 2 week on Day 1 of each cycle after last patient finishes DLT observation period. Dose expansion phase: One or two recommended expansion doses (either Q3W or Q2W) will be selected from 6 dose groups (0.01mg/kg, 0.03mg/kg, 0.1mg/kg, 0.2mg/kg, 0.3mg/kg 0.45mg/kg) based on results of dose escalation phase. MIL97 will be administered via intravenous infusion for 60 to 90 minutes on Day 1 of each cycle.
Treatment groups
62 Participants
are divided into 1 treatment groupGroup A: MIL97Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of MIL97 treatment-emergent adverse events in patients with advanced or metastatic solid tumor
incidence of AEs and SAEs assessed by NCI CTCAE v5.0.
Time frame
up to 2.5 year after enrollmentSecondary outcomes
1
Pharmacokinetics: AUC
The area under the curve (AUC) of serum concentration of the drug after the administration
Time frame
up to 1.5 year after enrollment2
Pharmacokinetics: Cmax;
Maximum concentration (Cmax) of the drug after administration
Time frame
up to 1.5 year after enrollment3
Objective response rate (ORR);
To evaluate preliminary anti-tumor activity of MIL97 in subjects with advanced or metastatic solid tumor. ORR includes complete remission (CR) and partial remission (PR) assessed by RECIST v1.1 criteria.
Time frame
up to 2.5 year after enrollment4
Duration of response (DoR);
DOR is defined as the time from the initial response (CR or PR) to the time of disease progression or death, whichever occurs first.
Time frame
up to 2.5 year after enrollmentSponsors and contacts
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Source ClinicalTrials.gov