A Clinical Study of MIL95 in Advanced Malignancies.

PHASE1RecruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

January 4, 2021

Primary Completion Date

December 8, 2022

Study Completion Date

November 30, 2024

Conditions
Advanced Malignancies
Interventions
DRUG

Recombinant Humanized Monoclonal Antibody MIL95

"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."

Trial Locations (1)

Unknown

RECRUITING

Beijing Cancer Hospital, Beijing

All Listed Sponsors
lead

Beijing Mabworks Biotech Co., Ltd.

INDUSTRY