ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors
NCT ID: NCT05405595
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
186 participants
INTERVENTIONAL
2022-06-15
2027-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of ADG106 In Combination With PD-1 Antibody In Advanced or Metastatic Solid Tumors and/or Non Hodgkin Lymphoma
NCT04775680
A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants with Advanced Unresectable or Metastatic Solid Tumors
NCT05572684
Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer
NCT03432598
Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers
NCT03254732
A Study to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody AK105 in Patients With Selected Advanced Solid Tumors
NCT04172506
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ADG126 in combination with Pembrolizumab (Trade name KEYTRUDA®)
An IV infusion of ADG126 over 60-90 minutes will be administered 30-60 minutes after administration of pembrolizumab (KEYTRUDA®) infusion. A treatment cycle will consist of 21 days. ADG126 and Pembrolizumab (KEYTRUDA®) combination treatment both will be dosed until progressive disease (PD), intolerable toxicities, withdrawals of consent, or up to 35 cycles.
ADG126
ADG126 is an anti-CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4.
Pembrolizumab (KEYTRUDA®)
Pembrolizumab (KEYTRUDA®) is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody).
ADG126 and pembrolizumab (KEYTRUDA®) in combination with Trifluridine/Tipiracil-Bevacizumab
To evaluate the preliminary antitumor efficacy of ADG126 and Pembrolizumab (KEYTRUDA®) in combination with SOC (Trifluridine/Tipiracil-Bevacizumab) while assessing safety and tolerability. Standard of care treatment will be administered according to the specifications outlined in the Investigational Brochure. Will be dosed until progressive disease (PD), intolerable toxicities, withdrawals of consent, or up to 35 cycles.
ADG126
ADG126 is an anti-CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4.
Pembrolizumab (KEYTRUDA®)
Pembrolizumab (KEYTRUDA®) is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody).
Standard of Care (Trifluridine/Tipiracil-Bevacizumab)
The standard of care therapies will include Trifluridine/Tipiracil-Bevacizumab, approved for treating metastatic colorectal cancer (CRC)and various solid tumors.
ADG126 and pembrolizumab (KEYTRUDA®) in combination with fruquintinib
To evaluate the preliminary antitumor efficacy of ADG126 and Pembrolizumab (KEYTRUDA®) in combination with SOC (Fruquintinib) while assessing safety and tolerability. The dose strength for treatment will be based on the IB and protocol. Fruquintinib (Fruzaqla) is orally given once daily for the first 21 days of each 28-day cycle. Each treatment cycle consists of 14 days. Will be dosed until progressive disease (PD), intolerable toxicities, withdrawals of consent, or up to 35 cycles.
ADG126
ADG126 is an anti-CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4.
Pembrolizumab (KEYTRUDA®)
Pembrolizumab (KEYTRUDA®) is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody).
Standard of care (Fruquintinib)
The standard of care therapy, Fruquintinib, is approved for treating metastatic colorectal cancer (CRC) and various solid tumors.
Dose Optimization
The randomized phase 2 Dose Optimization arm is intended to test two dosing regimens of ADG126 in combination with pembrolizumab (KEYTRUDA®), which allows the selection of an optimal regimen. The study treatments may continue for up to 35 treatments for pembrolizumab (KEYTRUDA®) if given every 21 days and 18 treatments for pembrolizumab (KEYTRUDA®) if given every 42 days until PD, intolerable toxicities or withdrawal of consent.
ADG126
ADG126 is an anti-CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4.
Pembrolizumab (KEYTRUDA®)
Pembrolizumab (KEYTRUDA®) is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ADG126
ADG126 is an anti-CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4.
Pembrolizumab (KEYTRUDA®)
Pembrolizumab (KEYTRUDA®) is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody).
Standard of Care (Trifluridine/Tipiracil-Bevacizumab)
The standard of care therapies will include Trifluridine/Tipiracil-Bevacizumab, approved for treating metastatic colorectal cancer (CRC)and various solid tumors.
Standard of care (Fruquintinib)
The standard of care therapy, Fruquintinib, is approved for treating metastatic colorectal cancer (CRC) and various solid tumors.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
3. Wash out period from previous antitumor therapies
4. At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
5. Adequate organ function.
6. An archival tumor biopsy is required and should be taken within 2 years of enrollment. If not available, a fresh tumor biopsy is acceptable.
7. For Dose Escalation Phase Only: Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists.
8. Dose Expansion Phase Only: Tumor tissues (archived tissue) before treatment are required for all patients.
Exclusion Criteria
2. Childbearing potential who does not agree to the use of contraception during the treatment period.
3. Treatment with any investigational drug within washout period.
4. Prior treatment with a PD-1, PD-L1 targeting agent or a next-generation anti-CTLA-4 therapy with enhanced ADCC function.
5. History of significant irAEs or irAE.
6. Central nervous system (CNS) disease involvement.
7. History or risk of autoimmune disease.
8. Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (\>10 mg/day prednisone or equivalent).
9. Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).
10. Major surgery within 4 weeks prior to the first dose of the study drug.
11. Has had an allogeneic tissue/solid organ transplant.
12. Has received a COVID-19 vaccine within 7 days prior to the first dose of study treatment. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment. Note: Administration of killed vaccines are allowed.
13. A positive COVID-19 test within 14 days of Cycle 1 Day 1.
14. History of Hypersensitivity or known to be allergic to protein drugs or recombinant protein.
15. Active hemoptysis or central airway invasion by metastatic tumor.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Adagene Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jiping Zha, MD, PhD
Role: STUDY_DIRECTOR
Adagene Inc
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Honor Health Research Institute
Scottsdale, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
City of Hope Orange County
Irvine, California, United States
Florida cancer specialist/Sarah Cannon Research Institute
Sarasota, Florida, United States
The Cleveland Clinic
Cleveland, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 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, South Korea
CHA Bundang Medical Center, CHA university
Seongnam, Gyeonggido, South Korea
The Catholic University of Korea Street. Vincent Hospital
Suwon, Gyeonggido, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
KangBuk Samsung Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Sharma Sunil, MD
Role: primary
Daneng Li, MD
Role: primary
Marwan Fakih, MD
Role: backup
Pashtoon Kasi, MD
Role: primary
Smitha Krishnamurthi, MD
Role: primary
David Hong, MD
Role: primary
Mary Trahan
Role: backup
Rachael Safyan, MD
Role: primary
Yu Chen, MD
Role: primary
Ruihua Xu, MD
Role: primary
George Lau, MD
Role: primary
Brigette B.Y Ma, MD
Role: primary
Hing Jae Chon, MD
Role: primary
Song I Kang
Role: backup
Ki Hyeong Lee, MD
Role: primary
Hee Kyung Kim, MD
Role: backup
Byoung Yong Shim, MD
Role: primary
Jee Yun Lee, MD
Role: backup
Seock -Ah Im, MD
Role: primary
Sae Won Han, MD
Role: backup
Sun Young Kim, MD
Role: primary
Ko Eun- Young
Role: backup
Sang Joon Shin, MD
Role: primary
Da Seul Lee
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KEYNOTE-C98, MK-3475-C98
Identifier Type: OTHER
Identifier Source: secondary_id
ADG126-P001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.