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

Myelodysplastic Syndrome Clinical Trial

— HATCH  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04691141
• Other study ID #: ATG-016-MDS-001
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: February 23, 2021
• Est. completion date: September 19, 2023

Study information

• Verified date: March 2024
• Source: Antengene Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: September 19, 2023
• Est. primary completion date: September 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

2. 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).

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.

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

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

Locations

Country	Name	City	State
China	Guangdong Provincal People's Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University, School of Medicine	Hangzhou	Zhejiang
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Shanghai the sixth people's hospital	Shanghai	Shanghai
China	Tianjin blood research institute	Tianjin	Tianjin
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Antengene Corporation Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD in Phase I	MTD will be evaluated using the NCI-CTCAE, Version 5.0	16 months
Primary	RP2D in Phase I	RP2D will be determined under the guidance of the SRC.	16 months
Primary	AEs/SAEs	Toxicity will be graded according to the NCI CTCAE, Version 5.0.	25 months
Primary	ORR in Phase II	Based on 2006 IWG Response Criteria, evaluated by IRC: ORR (CR + PR + mCR)	25 months
Secondary	Disease Control Rate (DCR) in Phase I/II	DCR (CR + PR + mCR + HI + SD)	12 months
Secondary	Duration of Response (DOR) in Phase I/II	To evaluate duration of response	12 months
Secondary	Progression-Free Survival (PFS) in Phase I/II	To evaluate progression-free survival	12 months
Secondary	Overall Survival (OS)	The estimates of Kaplan-Meier	12 months