ADG126Pembrolizumab (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)
Facility
City
Region
Status
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
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.
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