Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

ADG206 is an activatable prodrug form of a fully human monoclonal antibody (mAb) of the immunoglobulin G1 (IgG1) subclass that specifically targets cluster of differentiation 137 (CD137) (also known as 4-1BB) as a co-stimulatory receptor agonist for the treatment of advanced malignancies.

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

Details

• Lead Sponsor: Adagene Inc

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status ≤1.

• Subjects with advanced or metastatic solid tumors (except thymic tumors), which have progressed after all standard therapies, or no further standard therapies exists.

• At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

• Adequate organ function.

• Woman of childbearing potential must agree to use 2 methods of acceptable contraception from screening until 6 months after the last dose of study drug.

• Male subjects who are sexually active with a female partner of childbearing potential must agree to use a barrier contraception.

• An archival tumor biopsy is required and should be taken within 2 years of enrollment. If not available, a fresh tumor biopsy is acceptable.

Exclusion Criteria:

• Subjects within washout period of other anti-tumor therapies. .

• History of prior malignancy other than the cancer under treatment in the study.

• Major trauma or major surgery within 4 weeks before the first dose of study drug.

• Serious nonhealing wound, ulcer, or bone fracture.

• History of significant immune-mediated AE.

• Central nervous system (CNS) disease involvement.

• Any evidence of underlying severe liver dysfunction.

• Prior organ allograft transplantations or allogeneic bone marrow, cord blood or peripheral blood stem cell transplantation.

• Clinically significant cardiac disease with insufficient cardiac function.

• Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.

• Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).

• Infection of hepatitis B virus (HBV), or hepatitis C virus (HCV) (unless the disease is clinically controlled) .

• History or risk of autoimmune disease.

• Subjects with active severe lung infection or with a history of interstitial lung diseases, noninfectious pneumonitis, active pulmonary tuberculosis, or evidence of active pneumonitis. Clinically significant and unmanageable ascites defined as requiring constant therapeutic paracentesis.

• Any serious underlying issue that would limit compliance with study requirements, impair the ability of the subject to understand informed consent.

• Known hypersensitivity, allergies, or intolerance to immunoglobulins or to any excipient contained in ADG206.

• Pregnant, lactating, or breastfeeding.