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

• Sponsor: Shanghai Antengene Corporation Limited (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04691141
• Collaborator: (none)
• Enrollment: 59
• Locations: 6
• Arm: 1
• Anticipated Duration (Months): 32.5
• Patients Per Site: 9.8
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndrome	Drug: ATG-016	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 59 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 30, 2021
• Anticipated Primary Completion Date: Dec 7, 2023
• Anticipated Study Completion Date: Mar 16, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ATG-016 5 mg QD×Days 1-5/week will be the initial dose of this study.	Drug: ATG-016; 59 patients enrolled will be treated with 5 mg (QD×Days 1-5/week), orally, each 4 week (28-day) a cycle

Outcome Measures

Primary Outcome Measures

1. MTD in Phase I [16 months]

   MTD will be evaluated using the NCI-CTCAE, Version 5.0

2. RP2D in Phase I [16 months]

   RP2D will be determined under the guidance of the SRC.

3. AEs/SAEs [25 months]

   Toxicity will be graded according to the NCI CTCAE, Version 5.0.

4. ORR in Phase II [25 months]

   Based on 2006 IWG Response Criteria, evaluated by IRC: ORR (CR + PR + mCR)

Secondary Outcome Measures

1. Disease Control Rate (DCR) in Phase I/II [12 months]

   DCR (CR + PR + mCR + HI + SD)

2. Duration of Response (DOR) in Phase I/II [12 months]

   To evaluate duration of response

3. Progression-Free Survival (PFS) in Phase I/II [12 months]

   To evaluate progression-free survival

4. Overall Survival (OS) [12 months]

   The estimates of Kaplan-Meier

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong Provincal People's Hospital	Guangzhou	Guangdong	China	510000
2	Henan Cancer Hospital	Zhengzhou	Henan	China	450008
3	The Affiliated Hospital of Qingdao University	Qingdao	Shandong	China	266071
4	Shanghai the sixth people's hospital	Shanghai	Shanghai	China	201306
5	Tianjin blood research institute	Tianjin	Tianjin	China	300020
6	The First Affiliated Hospital, Zhejiang University, School of Medicine	Hangzhou	Zhejiang	China	310009

Sponsors and Collaborators

• Shanghai Antengene Corporation Limited

Investigators

• Principal Investigator: Zhijian Xiao, MD, Tianjin blood research institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Antengene Corporation Limited
• ClinicalTrials.gov Identifier: NCT04691141
• Other Study ID Numbers: ATG-016-MDS-001
• First Posted: Dec 31, 2020
• Last Update Posted: Aug 4, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome

Study Results

No Results Posted as of Aug 4, 2022