ADG116 in Patients With Advanced/Metastatic Solid Tumors

• Status: Recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1, open-label, dose escalation study in patients 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 is planned to treat up to 60 patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adagene Inc

Criteria

Inclusion Criteria:

• ≥18 years of age at the time of informed consent.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no deterioration over the previous 2 weeks.

• Patients with advanced or metastatic solid tumors, confirmed by histopathology, who have progressed after all standard therapies, or for whom no further standard therapy exists. Patients who have declined standard therapy or have no access to standard therapy may be enrolled and the reasons for lack of access need to be documented.

• Patients who are refractory or relapsed to prior anti-CTLA4 checkpoint inhibitors or anti Programmed cell death protein 1 (PD 1) will also be recruited if they meet all eligibility criteria.

• Adequate hematologic function

• Adequate renal function

• Previous antitumor therapy (including endocrine, chemoradiotherapy/ radiotherapy, targeted therapy, or immunotherapy) that has ended at least 4 weeks prior to administration of ADG116.

• Previous adverse events have been improved to baseline or ≤ Grade 1 NCI CTCAE v5.0 (except for patients with alopecia).

Exclusion Criteria:

• Pregnant or breastfeeding females.

• Treatment with any investigational drug within 4 weeks prior to the first dose of study drug.

• Grade ≥ 3 immune-related AEs (irAEs) or irAE that lead to discontinuation of prior immunotherapy.

• Patients with active autoimmune disease or a documented medical history of autoimmune disease.

• Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications within 21 days before the planned first dose of study drug.

• Active viral (any etiology) hepatitis patient are excluded.

• Known human immunodeficiency virus (HIV) positive status.

• Patients with any type of primary immunodeficiency or autoimmune disorder requiring treatment.

• Major surgery within 4 weeks prior to the first dose of the study drug.

• Clinically significant cardiac conditions.

• Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.

• Any known, documented, or suspected history of illicit substance abuse.

• Any other disease or clinically significant abnormality in laboratory parameters.