Status:
COMPLETED
A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors Patients
Lead Sponsor:
Adagene Inc
Conditions:
Advanced/Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase 1, open-label, dose escalation study in patients with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds t...
Eligibility Criteria
Inclusion
- Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- ≥ 18 years of age at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Patients with advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists.
- At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
- Adequate organ function.
Exclusion
- • Patients who meet any of the following criteria cannot be enrolled:
- 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.
- Grade ≥ 3 immune-related AEs (irAEs) or irAE that lead to discontinuation of prior immunotherapy.
- Central nervous system disease involvement
- History or risk of autoimmune disease.
- History of life-threatening hypersensitivity or known to be allergic to protein drugs or recombinant proteins or any ingredients contained in the ADG116 drug formulation.
- Patients requiring systemic treatment with corticosteroids
- Patients receiving granulocyte colony stimulating factor (G-CSF), within 14 days prior to the first dose of the study drug.
- 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.
Key Trial Info
Start Date :
September 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04501276
Start Date
September 23 2020
End Date
November 30 2025
Last Update
January 8 2026
Active Locations (4)
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1
Next Oncology
San Antonio, Texas, United States, 78229
2
Ashford Cancer Centre Research
Kurralta Park, Australia
3
Cabrini Hospital
Malvern, Australia
4
Macquarie University
Sydney, Australia