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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
59 patients enrolled will be treated with ATG-016, orally, each 4 week (28-day) a cycle
Guangdong Provincal People's Hospital
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Shanghai the sixth people's hospital
Shanghai, Shanghai Municipality, China
MTD in Phase I
MTD will be evaluated using the NCI-CTCAE, Version 5.0
Time frame: 16 months
RP2D in Phase I
RP2D will be determined under the guidance of the SRC.
Time frame: 16 months
AEs/SAEs
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
Time frame: 25 months
ORR in Phase II
Based on 2006 IWG Response Criteria, evaluated by IRC: ORR (CR + PR + mCR)
Time frame: 25 months
Disease Control Rate (DCR) in Phase I/II
DCR (CR + PR + mCR + HI + SD)
Time frame: 12 months
Duration of Response (DOR) in Phase I/II
To evaluate duration of response
Time frame: 12 months
Progression-Free Survival (PFS) in Phase I/II
To evaluate progression-free survival
Time frame: 12 months
Overall Survival (OS)
The estimates of Kaplan-Meier
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tianjin blood research institute
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China