A Clinical Study of MIL95 in Advanced Malignancies.
ConditionAdvanced Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Mabworks Biotech Co., Ltd.
About this trial
This study is composed of two stages: Part A initial dose escalation and Part B maintenance dose escalation. Both parts will adopt the classical 3+3 dose escalation design.
The starting dose for phase Ia part A is 0.1 mg/kg QW, followed by 3 dose cohorts (0.3mg/kg QW, 0.8mg/kg QW and 1mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 14 days.
Part B will have 5 dose cohorts(3mg/kg QW, 10mg/kg QW, 20mg/kg QW 30mg/kg QW and 45mg/kg QW). DLT observation period is 28 days. The subject number for each cohort in Part B will be increased to 6 if the subject number enrolled in each cohort is less than 6.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients, >=18 years of age;
Diagnosis of Refractory/relapsed lymphomas or solid tumor;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Life expectancy >=3 months;
Disqualifiers
Prior use of any anti-cancer therapy(including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc) within 4 weeks of study start;
Previous exposure to any drug targeting CD47 or SIRPα;
Major surgery within 4 weeks prior to the first administration or expected to undergo major surgery during the study treatment;
Live attenuated vaccine administrated within 4 weeks before the first administration or during the study period;
Trial design
Design model
Single group
Treatments tested in this trial
Recombinant Humanized Monoclonal Antibody MIL95
DrugPART A :The patients confirming to the eligibility criteria will be assigned to the 4 dose groups (0.1mg/kg, 0.3mg/kg, 0.8mg/kg, 1.0mg/kg, respectively) based on the sequence of inclusion. Each patient will receive an intravenous infusion of MIL95 every week on Day 1 for a maximum of Twelve weeks. PART B:One recommended dose as a priming dose will be selected from 4 dose groups(0.1mg/kg、0.3mg/kg、0.8mg/kg、1.0mg/kg) based on results of PART A. Each patient will receive a priming dose of MIL95 on Day 1 Cycle 1.The patients will be assigned to the 5 maintenance dose groups (3mg/kg, 10mg/kg, 20mg/kg, 30mg/kg, 45mg/kg, respectively) based on the sequence of inclusion. The maintenance dose was given on Day 8,15,22 Cycle 1 and on Day 1,8,15,22 Cycle 2+. Each cycle was 28 days.
Treatment groups
58 Participants
are divided into 1 treatment groupGroup A: MIL95Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants with Adverse Events
Percentage of Participants with AEs and SAEs assessed by NCI CTCAE v5.0.
Time frame
up to 1year 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 1year after enrollment2
Pharmacokinetics: Cmax
Maximum concentration(Cmax) of the drug after administration
Time frame
up to 1year after enrollment3
Objective response rate (ORR)
To evaluate preliminary anti-tumor activity of MIL95 in subjects with advanced malignancies.ORR includes complete remission(CR) and partial remission(PR) assessed by RECIST v1.1 criteria for solid tumors and Lugano2014 criteria for lymphoma.
Time frame
up to 1year 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 1year after enrollmentSponsors and contacts
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Source ClinicalTrials.gov