NCT04986865

A Study ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas

A First-in-Human Phase I Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Antengene Biologics Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a First-in-Human Phase I trial of ATG-101 in Patients with Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas.

Detailed description

This is a First-in-Human Phase I trial of ATG-101 in Patients with Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas. Dose Escalation Phase: Approximately 40-50 subjects with a maximum number of 62; Dose Expansion Phase: Estimated 100-400 subjects depending on the number of cohorts to be expanded.

Conditions

• Advanced Solid Tumor
• Metastatic Solid Tumor
• Mature B-cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	ATG-101	ATG-101 will be administered intravenously once every 21 days. During the Escalation Phase, the dose levels will be determined by the starting dose and the escalation steps taken in the trial. The Dose Expansion Phase will begin at the defined MTD, RP2D, or biologically optimal dose.

Timeline

• Start date: 2021-12-15
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2021-08-03
• Last updated: 2025-06-09

Locations

8 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study