Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors

Trial Title: Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors

NCT ID: NCT05614258

Condition: Advanced/Metastatic Solid Tumors

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: ADG206
Description: 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.
Arm group label: ADG206 dose escalation

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Ashford Cancer Centre Research

Address:
City: Kurralta Park
Zip: 5037
Country: Australia

Status: Recruiting

Contact:
Last name: Carolyn Bampton

Facility:
Name: Monash Health

Address:
City: Clayton
Zip: 3168
Country: Australia

Status: Recruiting

Contact:
Last name: Sophia Frentzas

Start date: February 13, 2023

Completion date: October 2025

Lead sponsor:
Agency: Adagene Inc
Agency class: Industry

Source: Adagene Inc

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05614258