Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors

NCT ID: NCT05614258

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-13
• Study Completion Date: 2026-08-30

Brief 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.

Detailed 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.

Conditions

Advanced/Metastatic Solid Tumors

Study Design

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

Study Groups

ADG206 dose escalation

Group Type: EXPERIMENTAL

ADG206

Intervention Type: DRUG

All participants in this study will receive the study drug ADG206 in one of the designed dosage level. ADG206 will be administered by intravenous infusion over 60-90 minutes on Day 1 of each treatment cycle until disease progression, intolerable toxicities or withdrawal of consent, or up to 2 years.

Interventions

ADG206

All participants in this study will receive the study drug ADG206 in one of the designed dosage level. ADG206 will be administered by intravenous infusion over 60-90 minutes on Day 1 of each treatment cycle until disease progression, intolerable toxicities or withdrawal of consent, or up to 2 years.

Intervention Type: DRUG

Eligibility 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.

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.

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

Sponsors

Adagene Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ashford Cancer Centre Research

Kurralta Park, South Australia, Australia

Monash Health

Clayton, Victoria, Australia

Countries

Australia

Other Identifiers

ADG206-1001

Identifier Type: -

Identifier Source: org_study_id