Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors

Study Overview
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Brief Summary
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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.

Official Title
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First-in-human (FIH), Open-Label, Phase I (Dose Escalation) Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: ADG116


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADG116<br> | Drug: ADG116<br>* IV infusion at Day 1 of each cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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) |