358
Participants
Start Date
May 30, 2023
Primary Completion Date
November 12, 2025
Study Completion Date
April 24, 2027
GI-102 subcutaneous (SC)
0.12 mg/kg, 0.24 mg/kg or Recommended phase 2 dose of GI-102 will be administered via SC injection Q3W up to 2 years (approximately 35 years).
GI-102
Dose level will be escalated from 0.06 mg/kg to 0.45 mg/kg and Recommended phase 2 dose (or RP2D-1, RP2D+1) of GI-102 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
doxorubicin
Doxorubicin will be administered intravenously at a dose of 75 mg/m2 on Day 3 every 3-week (21-day) cycle for up to 6 cycles.
paclitaxel
Paclitaxel will be administered intravenously over 1 hour at a dose of 80 mg/m2 each time weekly as a diluted solution according to the prescribing information.
bevacizumab
Bevacizumab will be administered intravenously at a dose of 10 mg/kg every 2 weeks.
eribulin
Eribulin will be administered intravenously at a dose of over 1.4 mg/m2 over 2 to 5 minutes on Days 3 and 10 every 3-week (21-day) cycle.
trastuzumab deruxtecan (T-DXd)
T-DXd will be administered initially as a 5.4 mg/kg (or 6.4 mg/kg only for gastric cancer) IV over 30 - 90 minutes every 3 weeks.
pembrolizumab
pembrolizumab will be administered at a dose of 200 mg as IV infusion Q3W.
GI-102
Recommended phase 2 dose (or RP2D-1, RP2D-2) of GI-102 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
RECRUITING
Memorial Sloan-Kettering Cancer Center, New York
RECRUITING
St. Vincent's Hospital, Suwon
RECRUITING
Mayo Clinic in Florida, Jacksonville
RECRUITING
Cleveland Clinic, Cleveland
RECRUITING
Mayo Clinic in Minnesota, Rochester
RECRUITING
Mayo Clinic in Arizona, Scottsdale
RECRUITING
Seoul National University Hospital, Seoul
RECRUITING
Yonsei University Health System, Severance Hospital, Seoul
RECRUITING
Yonsei University Health System, Severance Hospital, Seoul
RECRUITING
Asan Medical Center, Seoul
RECRUITING
Samsung Medical Center, Seoul
Lead Sponsor
Merck Sharp & Dohme LLC
INDUSTRY
GI Innovation, Inc.
INDUSTRY