Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in South Korea / NCT05405595
Recruiting Phase 1/2

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

NCT05405595 · tracked via the Priya Life Science South Korea tracker
Sponsor
Adagene Inc
Phase
Phase 1/2
Started
2022-06-15
Last updated
2026-01-07

Condition(s) studied

Advanced/Metastatic Solid Tumors

Investigational drug(s) / intervention(s)

ADG126 →Pembrolizumab (KEYTRUDA®) →Standard of Care (Trifluridine/Tipiracil-Bevacizumab)Standard of care (Fruquintinib)

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.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. ≥18 years of age at the time of informed consent. 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: 1. Pregnant or breastfeeding females. 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.

Primary outcome measure(s)

  • Maximum tolerated dose (MTD) and RP2D for ADG126 in combination with pembrolizumab. — 9 months
    To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) for ADG126+ pembrolizumab in dose escalation levels
  • the safety and tolerability of ADG126 at escalating dose level in combination with pembrolizumab in adults with advanced metastatic solid tumors — 9 months
    Incidence rate of AEs as assessed by CTCAE v5.0
  • Access the preliminary antitumor activity of ADG126-pembrolizumab combination regimens — 9 months
    Number of Participants with preliminary antitumor activity
  • Maximum tolerated dose (MTD) and/or RP2D for ADG126 with Trifluridine/Tipiracil-Bevacizumab — 6 months
    To assess the safety and tolerability of ADG126 + pembrolizumab in combination with the following SOC therapies (Trifluridine/tipiracil-bevacizumab) in MSS CRC To determine the MTD and/or RP2D for ADG126 + pembrolizumab in combination with the following SOC therapies in MSS CRC:
  • Access the preliminary antitumor activity of ADG126 with Pembrolizumab in combination standard of care — 6 months
    To assess the preliminary antitumor activity of ADG126 + pembrolizumab in combination with the following SOC therapies in MSS CRC (Trifluridine/tipiracil-bevacizumab) SOC (Fruquintinib)
  • Access and characterize the optimal dose based on safety and efficacy parameters — 9 months
    To characterize the optimal dose based on safety and efficacy parameters

Trial sites (21)

FacilityCityRegionStatus
Honor Health Research Institute Scottsdale Arizona Recruiting
City of Hope National Medical Center Duarte California Recruiting
City of Hope Orange County Irvine California Recruiting
Florida cancer specialist/Sarah Cannon Research Institute Sarasota Florida Active Not Recruiting
The Cleveland Clinic Cleveland Ohio Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
Fujian Cancer Hospital Fuzhou Fujian Recruiting
SunYat-Sen University Cancer Center Guangzhou Guangdong Recruiting
Hong Kong Humanity & Health Clinical Trial Center Hong Kong Hong Kong Recruiting
Prince of Wales Hospital Hong Kong Hong Kong Recruiting
Dong -A University Hospital Seogu Busan Gwangyeogsi Terminated
CHA Bundang Medical Center, CHA university Seongnam Gyeonggido Recruiting
The Catholic University of Korea Street. Vincent Hospital Suwon Gyeonggido Terminated
Chungbuk National University Hospital Cheongju-si North Chungcheong Recruiting
Samsung Medical Center Seoul Seoul Teugbyeolsi Recruiting
Keimyung University Dongsan Hospital Daegu South Korea Terminated
Seoul National University Hospital Seoul South Korea Recruiting
KangBuk Samsung Hospital Seoul South Korea Terminated
Asan Medical Center Seoul South Korea Recruiting
Severance Hospital Yonsei University Health System Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05405595 on ClinicalTrials.gov ↗ ← All trials in South Korea