Back to resultsA Study to Evaluating the Pharmacokinetics, Safety, and Efficacy of ATG 016 Monotherapy in IPSS-R Intermediate Risk and Above Myelodysplastic Syndrome (MDS) (HATCH)
Primary Purpose
Myelodysplastic Syndrome
Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ATG-016
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome
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 ≤2.
- 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.
Sites / Locations
- Guangdong Provincal People's Hospital
- Henan Cancer Hospital
- The Affiliated Hospital of Qingdao University
- Shanghai the sixth people's hospital
- Tianjin blood research institute
- The First Affiliated Hospital, Zhejiang University, School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ATG-016
Arm Description
5 mg QD×Days 1-5/week will be the initial dose of this study.
Outcomes
Primary Outcome Measures
MTD in Phase I
MTD will be evaluated using the NCI-CTCAE, Version 5.0
RP2D in Phase I
RP2D will be determined under the guidance of the SRC.
AEs/SAEs
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
ORR in Phase II
Based on 2006 IWG Response Criteria, evaluated by IRC: ORR (CR + PR + mCR)
Secondary Outcome Measures
Disease Control Rate (DCR) in Phase I/II
DCR (CR + PR + mCR + HI + SD)
Duration of Response (DOR) in Phase I/II
To evaluate duration of response
Progression-Free Survival (PFS) in Phase I/II
To evaluate progression-free survival
Overall Survival (OS)
The estimates of Kaplan-Meier
Full Information
NCT ID
NCT04691141
First Posted
December 23, 2020
Last Updated
August 2, 2023
Sponsor
Shanghai Antengene Corporation Limited
1. Study Identification
Unique Protocol Identification Number
NCT04691141
Brief Title
A Study to Evaluating the Pharmacokinetics, Safety, and Efficacy of ATG 016 Monotherapy in IPSS-R Intermediate Risk and Above Myelodysplastic Syndrome (MDS)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
December 7, 2023 (Anticipated)
Study Completion Date
March 16, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Antengene Corporation Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ATG-016
Arm Type
Experimental
Arm Description
5 mg QD×Days 1-5/week will be the initial dose of this study.
Intervention Type
Drug
Intervention Name(s)
ATG-016
Intervention Description
59 patients enrolled will be treated with ATG-016, orally, each 4 week (28-day) a cycle
Primary Outcome Measure Information:
Title
MTD in Phase I
Description
MTD will be evaluated using the NCI-CTCAE, Version 5.0
Time Frame
16 months
Title
RP2D in Phase I
Description
RP2D will be determined under the guidance of the SRC.
Time Frame
16 months
Title
AEs/SAEs
Description
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
Time Frame
25 months
Title
ORR in Phase II
Description
Based on 2006 IWG Response Criteria, evaluated by IRC: ORR (CR + PR + mCR)
Time Frame
25 months
Secondary Outcome Measure Information:
Title
Disease Control Rate (DCR) in Phase I/II
Description
DCR (CR + PR + mCR + HI + SD)
Time Frame
12 months
Title
Duration of Response (DOR) in Phase I/II
Description
To evaluate duration of response
Time Frame
12 months
Title
Progression-Free Survival (PFS) in Phase I/II
Description
To evaluate progression-free survival
Time Frame
12 months
Title
Overall Survival (OS)
Description
The estimates of Kaplan-Meier
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 ≤2.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhijian Xiao, MD
Organizational Affiliation
Tianjin blood research institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincal People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266071
Country
China
Facility Name
Shanghai the sixth people's hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201306
Country
China
Facility Name
Tianjin blood research institute
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University, School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluating the Pharmacokinetics, Safety, and Efficacy of ATG 016 Monotherapy in IPSS-R Intermediate Risk and Above Myelodysplastic Syndrome (MDS)
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