Actively Recruiting
A Phase 1b/2, Open-Label, Dose Escalation and Expansion Study of ADG126 in Combination With Pembrolizumab (Anti PD-1 Antibody) in Patients With Advanced/Metastatic Solid Tumors
Led by Adagene Inc · Updated on 2026-01-07
186
Participants Needed
21
Research Sites
25 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
Researchers are studying the safety, tolerability, pharmacokinetics, and immune response of ADG126 combined with pembrolizumab in adults with advanced or metastatic solid tumors. This Phase 1b/2 open-label study focuses on various solid tumors, especially microsatellite stable colorectal cancer (MSS CRC). The study includes dose escalation, expansion, and optimization phases to find the best dosing regimen. Participants receive ADG126, an antibody targeting CTLA-4, and pembrolizumab, a PD-1 blocking antibody, through intravenous infusions every 21 days. Some study groups also receive standard care treatments like trifluridine/tipiracil-bevacizumab or fruquintinib. Treatment continues until disease progression, intolerable side effects, withdrawal, or up to 35 cycles. The Phase 2 portion uses randomization to compare two dosing schedules of ADG126 with pembrolizumab. During the study, participants undergo regular assessments including tumor measurements, blood tests, and safety monitoring. Researchers track drug levels, immune responses, disease control, progression-free survival, and overall survival, with follow-up lasting up to two years. Participants may have tumor biopsies and are monitored for adverse events and treatment effects throughout their involvement.
CONDITIONS
Brief 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 of 0 or 1
- Completed required washout period from previous antitumor therapies
- At least one measurable tumor lesion at baseline per RECIST v1.1 criteria
- Adequate organ function as determined by study tests
- Archival tumor biopsy taken within 2 years or a fresh tumor biopsy before enrollment
- For Dose Escalation Phase: Histologically or cytologically confirmed locally advanced or metastatic solid tumors after standard therapies
- For Dose Expansion Phase: Archived tumor tissue required before treatment
You will not qualify if you...
- Pregnant or breastfeeding females
- Persons of childbearing potential unwilling to use contraception during treatment
- Treatment with any investigational drug within required washout period
- Prior treatment with PD-1, PD-L1 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 immunosuppressives above 10 mg/day prednisone equivalent
- Uncontrolled active infections or poorly controlled asthma or COPD
- Major surgery within 4 weeks before first study drug dose
- Prior allogeneic tissue or solid organ transplant
- COVID-19 vaccine within 7 days or live vaccine within 30 days before first dose
- Positive COVID-19 test within 14 days before first dose
- Known allergy or hypersensitivity to protein drugs or recombinant proteins
- Active hemoptysis or central airway invasion by metastatic tumor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years depending on treatment cycles
Participants receive treatment cycles consisting of ADG126 and Pembrolizumab, alone or in combination with other drugs, administered until disease progression, intolerable side effects, withdrawal, or up to 35 cycles.
Treatment cycles every 21 to 42 days with dosing visits accordingly
Duration - Up to 2 years following the last dose
Participants are monitored for safety, tolerability, and efficacy outcomes after completing treatment or upon discontinuation.
Regular follow-up visits as scheduled by the study
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
J
Jiping Zha, MD, PhD
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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