A Phase I/II, Open-label Study to Investigate the Pharmacokinetics, Safety, and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and Above Myelodysplastic Syndrome (MDS) Patients After Failure of Hypomethylating Agent (HMA)-Based Therapy

Shanghai Antengene Corporation Limited6 sites in 1 country15 target enrollmentFebruary 23, 2021

ConditionsMyelodysplastic Syndrome

InterventionsATG-016

DrugsATG-016

Overview

Phase: Phase 1
Intervention: ATG-016
Conditions: Myelodysplastic Syndrome
Sponsor: Shanghai Antengene Corporation Limited
Enrollment: 15
Locations: 6
Primary Endpoint: AEs/SAEs
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Detailed Description

This is a Phase Ⅰ/II, Open-label Study to Investigate the Pharmacokinetics, Safety, and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and above Myelodysplastic Syndrome (MDS) Patients after Failure of Hypomethylating Agent (HMA)-based Therapy. In Phase I: approximately 15 to 21 subjects and Phase II: approximately 44 subjects; approximately 59 to 65 subjects will be enrolled totally in this study.

Registry

clinicaltrials.gov

Start Date

February 23, 2021

End Date

September 19, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Antengene Corporation Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
•≥18 years of age, males or females.
•Eastern Cooperative Oncology Group (ECOG) performance status of ≤
•A life expectancy longer than 3 months in the opinion of the investigator at the screening.
•Male subjects (Including those who have received vasectomy) must agree to use condoms during sex with a woman of childbearing age and have no plans to impregnate the woman throughout the study and for 3 months following the last dose after the date of signing the ICF.

Exclusion Criteria

•History of central nervous system (CNS) involvement.
•Toxicity from prior antitumor therapy did not return to Grade 1 or baseline (Except for alopecia, neutropenia, anemia, and thrombocytopenia. For neutrophils, hemoglobin, and platelets, please follow Exclusion Criteria No. 5).
•History of human immunodeficiency virus (HIV) infection.
•History of severe bleeding disorder, such as hemophilia A, hemophilia B, and vascular hemophilia.
•History of allogeneic stem-cell transplantation.
•Serious psychiatric or medical conditions that, in the opinion of the investigator, could interfere with treatment, compliance, or the ability to give consent.
•Pregnant or lactating women.