ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced/Metastatic Solid Tumors

In brief

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).

Key facts

Study ID

NCT05405595

Run by

Adagene Inc

People needed

186

Starts

2022-06-15

Expected to finish

2027-04-30

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥18 years of age at the time of informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Wash out period from previous antitumor therapies
• At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
• Adequate organ function.
• An archival tumor biopsy is required and should be taken within 2 years of enrollment. If not available, a fresh tumor biopsy is acceptable.
• 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.
• Dose Expansion Phase Only: Tumor tissues (archived tissue) before treatment are required for all patients.

You may not qualify if…

• Pregnant or breastfeeding females.
• Childbearing potential who does not agree to the use of contraception during the treatment period.
• Treatment with any investigational drug within washout period.
• Prior treatment with a PD-1, PD-L1 targeting agent or a next-generation anti-CTLA-4 therapy with enhanced ADCC function.
• History of significant irAEs or irAE.
• Central nervous system (CNS) disease involvement.
• History or risk of autoimmune disease.
• Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (>10 mg/day prednisone or equivalent).
• Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).
• Major surgery within 4 weeks prior to the first dose of the study drug.
• Has had an allogeneic tissue/solid organ transplant.
• 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.
• A positive COVID-19 test within 14 days of Cycle 1 Day 1.
• History of Hypersensitivity or known to be allergic to protein drugs or recombinant protein.
• Active hemoptysis or central airway invasion by metastatic tumor.

Where it is running

• Severance Hospital Yonsei University Health System — Seoul, South Korea (enrolling)
• City of Hope National Medical Center — Duarte, California, United States (enrolling)
• City of Hope Orange County — Irvine, California, United States (enrolling)
• Chungbuk National University Hospital — Cheongju-si, North Chungcheong, South Korea (enrolling)
• Samsung Medical Center — Seoul, Seoul Teugbyeolsi, South Korea (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• Asan Medical Center — Seoul, South Korea (enrolling)
• Honor Health Research Institute — Scottsdale, Arizona, United States (enrolling)
• The Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (enrolling)
• SunYat-Sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
• Hong Kong Humanity & Health Clinical Trial Center — Hong Kong, Hong Kong, China (enrolling)
• Prince of Wales Hospital — Hong Kong, Hong Kong, China (enrolling)
• CHA Bundang Medical Center, CHA university — Seongnam, Gyeonggido, South Korea (enrolling)
• Florida cancer specialist/Sarah Cannon Research Institute — Sarasota, Florida, United States
• KangBuk Samsung Hospital — Seoul, South Korea
• The Catholic University of Korea Street. Vincent Hospital — Suwon, Gyeonggido, South Korea
• Keimyung University Dongsan Hospital — Daegu, South Korea
• Dong -A University Hospital — Seogu, Busan Gwangyeogsi, South Korea

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.