NCT05718895

A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors

An Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients With Advanced/Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Antengene Biologics Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients with Advanced/metastatic Solid Tumors

Detailed description

This is a Phase I, multi-center, open-label, dose-finding study of ATG-022 in patients with advanced solid tumours. The study design includes a Dose Escalation Phase which will enroll subjects with advanced/metastatic solid tumors, and a Dose Expansion Phase which will enroll select advanced/metastatic solid tumors with Claudin 18.2-positive expression at the defined maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) to further evaluate the safety, tolerability, and efficacy of ATG-022.

Conditions

• Advanced/Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	ATG-022	Dose Escalation Phase: A treatment cycle of ATG-022 will be defined as 21 days. Dosing will begin at 0.3 mg/kg once every 3 weeks (Q3W) with 1 subject ,the following dose cohorts (0.9, 1.8, 2.4, 3.0, and 3.6 mg/kg Q3W) will require at least 3 and up to 6 evaluable subjects by using dose escalation plan of "3+3" design.

Timeline

• Start date: 2023-03-27
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2023-02-08
• Last updated: 2026-04-15

Locations

22 sites across 2 countries: Australia, China