Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors

NCT ID: NCT04111445

Last Updated: 2021-09-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-29
• Study Completion Date: 2021-04-27

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.

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADG116

Group Type: EXPERIMENTAL

ADG116

Intervention Type: DRUG

IV infusion at Day 1 of each cycle

Interventions

ADG116

IV infusion at Day 1 of each cycle

Intervention Type: DRUG

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adagene Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NEXT Oncology

San Antonio, Texas, United States

Countries

United States

Other Identifiers

ADG116-1001

Identifier Type: -

Identifier Source: org_study_id