Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors

• Status: Terminated
• Trial end date: 2021-04-27
• Target enrollment: 0
• Participant gender: All

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 specifically binds to human CTLA-4. ADG 116 administered intravenously (IV) over a period of 60-90 minutes. The study planned to treated 42 patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adagene Inc

Criteria

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.