A Study to Evaluating the Pharmacokinetics, Safety, and Efficacy of ATG 016 Monotherapy in IPSS-R Intermediate Risk and Above Myelodysplastic Syndrome (MDS)
- Registration Number
- NCT04691141
- Lead Sponsor
- Shanghai Antengene Corporation Limited
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ATG-016 ATG-016 5 mg QD×Days 1-5/week will be the initial dose of this study.
- Primary Outcome Measures
Name Time Method AEs/SAEs 25 months Toxicity will be graded according to the NCI CTCAE, Version 5.0.
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.
ORR in Phase II 25 months Based on 2006 IWG Response Criteria, evaluated by IRC: ORR (CR + PR + mCR)
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (6)
Shanghai the sixth people's hospital
🇨🇳Shanghai, Shanghai, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Tianjin blood research institute
🇨🇳Tianjin, Tianjin, China
Guangdong Provincal People's Hospital
🇨🇳Guangzhou, Guangdong, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
The First Affiliated Hospital, Zhejiang University, School of Medicine
🇨🇳Hangzhou, Zhejiang, China