Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors

Adagene

Status and phase

Active, not recruiting

Phase 1

Conditions

Advanced/Metastatic Solid Tumors

Treatments

Drug: ADG206

Study type

Interventional

Funder types

Industry

Identifiers

NCT05614258

ADG206-1001

Details and patient eligibility

About

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.

Full description

This is a FIH, Phase 1, open-label, multicenter, sequential dose escalation study to evaluate the safety, tolerability, Pharmacokinetics (PK), and preliminary efficacy of ADG206 in subjects with advanced/metastatic malignancies.

Primary Objective of the study: To assess safety and tolerability at increasing dose levels of ADG206 in subjects with advanced/metastatic solid tumors who have exhausted their treatment alternatives.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

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.