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
Qualifiers
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
Treatments tested in this trial
- Recombinant Humanized Monoclonal Antibody MIL95
Treatment groups
58 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov