Treatment of Advanced and Metastatic Solid Tumors With MIL97

PHASE1RecruitingINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

January 18, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Advanced or Metastatic Solid Tumor
Interventions
DRUG

Recombinant Humanized Monoclonal Antibody MIL97 for Injection

"Dose 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."

Trial Locations (1)

100853

RECRUITING

Chinese PLA General Hospital, Beijing

All Listed Sponsors
lead

Beijing Mabworks Biotech Co., Ltd.

INDUSTRY