Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors

Adagene

Status and phase

Terminated

Phase 1

Conditions

Solid Tumor

Treatments

Drug: ADG116

Study type

Interventional

Funder types

Industry

Identifiers

NCT04111445

ADG116-1001

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.