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

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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04691141

Acronym

HATCH

Enrollment

Registered

2020-12-31

Start date

2021-02-23

Completion date

2023-09-19

Last updated

2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndrome

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.

Interventions

DRUGATG-016

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
ORR in Phase II	25 months	Based on 2006 IWG Response Criteria, evaluated by IRC: ORR (CR + PR + mCR)
MTD in Phase I	16 months	MTD will be evaluated using the NCI-CTCAE, Version 5.0
RP2D in Phase I	16 months	RP2D will be determined under the guidance of the SRC.
AEs/SAEs	25 months	Toxicity will be graded according to the NCI CTCAE, Version 5.0.

Secondary

Measure	Time frame	Description
Disease Control Rate (DCR) in Phase I/II	12 months	DCR (CR + PR + mCR + HI + SD)
Duration of Response (DOR) in Phase I/II	12 months	To evaluate duration of response
Progression-Free Survival (PFS) in Phase I/II	12 months	To evaluate progression-free survival
Overall Survival (OS)	12 months	The estimates of Kaplan-Meier

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026