Status:
TERMINATED
Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors
Lead Sponsor:
Adagene Inc
Conditions:
Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a FIH, open-label, Phase I dose-escalation study of ADG116 in subjects with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specif...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male or female, 18-75 years of age at the time of consent.
- Provide written informed consent.
- Subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor who have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available
- Patients who are refractory or relapsed to prior anti-CTLA4 checkpoint inhibitors will also be recruited if they meet all eligibility criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status \< 2.
- Adequate organ and bone marrow function
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within the 7 days prior to study
- Exclusion Criteria:
- Pregnant or nursing females.
- Treatment with any investigational drug within 4 weeks prior to the first dose of study drug
- Grade ≥ 3 immune-related adverse events (irAE) or irAE that lead to discontinuation of prior immunotherapy. Untreated or uncontrolled central nervous system (CNS) tumors or metastases
- Any active autoimmune disease or documented history of autoimmune disease.
- Infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- Subjects requiring systemic treatment with corticosteroids or other immunosuppressive medications within 21 days before the planned first dose of study drug.
- Current or prior history of pneumonitis, hepatitis, nephritis, colitis or thyroiditis. Peripheral neuropathy ≥ Grade 2.
- History of clinically significant cardiac disease.
- Uncontrolled current illness.
Exclusion
Key Trial Info
Start Date :
August 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04111445
Start Date
August 29 2019
End Date
April 27 2021
Last Update
September 10 2021
Active Locations (1)
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1
NEXT Oncology
San Antonio, Texas, United States, 78229