ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors
Start Date
6/15/2022
Completion Date
4/30/2027
Summary
This is a Phase 1b/2, open-label, dose escalation, dose expansion and dose optimization study to evaluate the safety, tolerability, PK, and immunogenicity of ADG126-pembrolizumab combination regimens in patients with advanced/metastatic solid tumors. The study drug ADG126 is an anti-CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. Pembrolizumab is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody).
Detailed Description
This is a Phase 1b/2, open-label, multicenter, dose escalation, dose expansion and dose optimization study to evaluate the safety, tolerability, PK, and preliminary efficacy of ADG126-Pembrolizumab or ADG126-Pembrolizumab in combination with trifluridine/tipiracil-bevacizumab or fruquintinib in patients with advanced/metastatic solid tumors, with a focus on MSS CRC. In Phase 2, the study will use a randomized design to evaluate the dose optimization regimen in patients with MSS CRC for ADG126- Pembrolizumab doublet only.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ADG126
Pembrolizumab (KEYTRUDA®)
Standard of Care (Trifluridine/Tipiracil-Bevacizumab)
Standard of care (Fruquintinib)
Conditions
Locations
Honor Health Research Institute
Scottsdale, Arizona 85251
United States
City of Hope National Medical Center
Duarte, California 91010
United States
City of Hope Orange County
Irvine, California 92618
United States
Florida cancer specialist/Sarah Cannon Research Institute
Sarasota, Florida 34232
United States
The Cleveland Clinic
Cleveland, Ohio 44195-0001
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
Fujian Cancer Hospital
Fuzhou, Fujian
China
SunYat-Sen University Cancer Center
Guangzhou, Guangdong
China
Hong Kong Humanity & Health Clinical Trial Center
Hong Kong, Hong Kong
China
Prince of Wales Hospital
Hong Kong, Hong Kong
China
Dong -A University Hospital
Seogu, Busan Gwangyeogsi 49201
South Korea
CHA Bundang Medical Center, CHA university
Seongnam, Gyeonggido 13496
South Korea
The Catholic University of Korea Street. Vincent Hospital
Suwon, Gyeonggido 16247
South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong 28644
South Korea
Samsung Medical Center
Seoul, Seoul Teugbyeolsi 06351
South Korea
Keimyung University Dongsan Hospital
Daegu, 41931
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
KangBuk Samsung Hospital
Seoul, 03081
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Severance Hospital Yonsei University Health System
Seoul, 3722
South Korea