A Study to Evaluating the Pharmacokinetics, Safety, and Efficacy of ATG 016 Monotherapy in IPSS-R Intermediate Risk and Above Myelodysplastic Syndrome (MDS)

NCT ID: NCT04691141

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2023-09-19

Brief Summary

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.

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.

Conditions

Myelodysplastic Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ATG-016

5 mg QD×Days 1-5/week will be the initial dose of this study.

Group Type: EXPERIMENTAL

ATG-016

Intervention Type: DRUG

59 patients enrolled will be treated with ATG-016, orally, each 4 week (28-day) a cycle

Interventions

ATG-016

59 patients enrolled will be treated with ATG-016, orally, each 4 week (28-day) a cycle

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.

2. ≥18 years of age, males or females.

3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.

4. A life expectancy longer than 3 months in the opinion of the investigator at the screening.

5. 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

1. History of central nervous system (CNS) involvement.

3. History of human immunodeficiency virus (HIV) infection.

4. History of severe bleeding disorder, such as hemophilia A, hemophilia B, and vascular hemophilia.

5. History of allogeneic stem-cell transplantation.

6. Serious psychiatric or medical conditions that, in the opinion of the investigator, could interfere with treatment, compliance, or the ability to give consent.

7. Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Antengene Corporation Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhijian Xiao, MD

Role: PRINCIPAL_INVESTIGATOR

Tianjin blood research institute

Locations

Guangdong Provincal People's Hospital

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Shanghai the sixth people's hospital

Shanghai, Shanghai Municipality, China

Tianjin blood research institute

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

ATG-016-MDS-001

Identifier Type: -

Identifier Source: org_study_id