Actively Recruiting
ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors
Led by Adagene Inc · Updated on 2026-01-07
186
Participants Needed
21
Research Sites
254 weeks
Total Duration
On this page
Sponsors
A
Adagene Inc
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Completed washout period from previous antitumor therapies
- At least one measurable tumor lesion at baseline per RECIST v1.1
- Adequate organ function
- Archival tumor biopsy taken within 2 years of enrollment or fresh biopsy if archival not available
- For Dose Escalation Phase: histologically or cytologically confirmed locally advanced or metastatic solid tumors with progression after all standard therapies or no further standard therapy available
- For Dose Expansion Phase: available archived tumor tissue before treatment
You will not qualify if you...
- Pregnant or breastfeeding women
- Women of childbearing potential not agreeing to contraception during treatment
- Treatment with any investigational drug during washout period
- Prior treatment with PD-1, PD-L1 targeting agents or next-generation anti-CTLA-4 therapies with enhanced ADCC
- History of significant immune-related adverse events
- Central nervous system (CNS) disease involvement
- History or risk of autoimmune disease
- Need for systemic corticosteroids or other immunosuppressive medications exceeding 10 mg/day prednisone equivalent
- Uncontrolled active infections or poorly controlled asthma or COPD
- Major surgery within 4 weeks before first study drug dose
- History of allogeneic tissue or solid organ transplant
- Received COVID-19 vaccine within 7 days or live vaccine within 30 days before first dose
- Positive COVID-19 test within 14 days of treatment start
- Known allergy or hypersensitivity to protein or recombinant protein drugs
- Active hemoptysis or central airway invasion by metastatic tumor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Honor Health Research Institute
Scottsdale, Arizona, United States, 85251
Actively Recruiting
2
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
3
City of Hope Orange County
Irvine, California, United States, 92618
Actively Recruiting
4
Florida cancer specialist/Sarah Cannon Research Institute
Sarasota, Florida, United States, 34232
Active, Not Recruiting
5
The Cleveland Clinic
Cleveland, Ohio, United States, 44195-0001
Actively Recruiting
6
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
7
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
8
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
9
SunYat-Sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
10
Hong Kong Humanity & Health Clinical Trial Center
Hong Kong, Hong Kong, China
Actively Recruiting
11
Prince of Wales Hospital
Hong Kong, Hong Kong, China
Actively Recruiting
12
Dong -A University Hospital
Seogu, Busan Gwangyeogsi, South Korea, 49201
Terminated
13
CHA Bundang Medical Center, CHA university
Seongnam, Gyeonggido, South Korea, 13496
Actively Recruiting
14
The Catholic University of Korea Street. Vincent Hospital
Suwon, Gyeonggido, South Korea, 16247
Terminated
15
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea, 28644
Actively Recruiting
16
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
17
Keimyung University Dongsan Hospital
Daegu, South Korea, 41931
Terminated
18
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
19
KangBuk Samsung Hospital
Seoul, South Korea, 03081
Terminated
20
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
21
Severance Hospital Yonsei University Health System
Seoul, South Korea, 3722
Actively Recruiting
Research Team
X
Xiaohong She, MS
CONTACT
J
Jiping Zha, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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