Description:
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.
Title
- Brief Title: Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors
- Official Title: First-in-human (FIH), Open-Label, Phase I (Dose Escalation) Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
ADG116-1001
- NCT ID:
NCT04111445
Conditions
Interventions
Drug | Synonyms | Arms |
---|
ADG116 | | ADG116 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
ADG116 | Experimental | | |
Eligibility 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 irAEs 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.
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of participants experiencing dose-limiting toxicities |
Time Frame: | From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Adagene Inc |
Last Updated
August 4, 2020