NCT05614258

Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors

A First-in-Human (FIH), Open-Label, Phase 1 Study of ADG206, a CD137 Agonist Antibody, in Subjects With Advanced/Metastatic Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Adagene Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2023-02-13
• Primary completion: 2025-06-25
• Completion: 2026-08-30
• First posted: 2022-11-14
• Last updated: 2026-01-08

Locations

2 sites across 1 country: Australia