Beijing Cancer Hospital
Beijing, China
Location status: Recruiting
Location contact
Yuqin Song, doctor
CONTACT
NCT Number: NCT04651348
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Beijing, China
Location status: Recruiting
Yuqin Song, doctor
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PART 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.
Time frame: up to 1year after enrollment
Percentage of Participants with AEs and SAEs assessed by NCI CTCAE v5.0.
Time frame: up to 1year after enrollment
The area under the curve (AUC) of serum concentration of the drug after the administration
Time frame: up to 1year after enrollment
Maximum concentration(Cmax) of the drug after administration
Time frame: up to 1year after enrollment
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 enrollment
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 enrollment
Defined as the time from the first day of study treatment to disease progression or death, whichever occurs first.
Time frame: up to 1year after enrollment
Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of MIL95.
Contact information is provided by the study sponsor or research team.
Beijing Mabworks Biotech Co., Ltd.
Industry
A Phase I Clinical Study of Recombinant Humanized Monoclonal Antibody MIL95 Injection in the Treatment of Lymphomas and Advanced Malignant Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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