Solid Tumor
Conditions
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 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.
Interventions
DRUGADG116
IV infusion at Day 1 of each cycle
Sponsors
Adagene Inc
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants experiencing dose-limiting toxicities | From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years) |
| Number of participants experiencing clinical and laboratory adverse events (AEs) | From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years) |
Countries
United States
Outcome results
None listed