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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)
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 ID: NCT04691141
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, China
Tianjin blood research institute, Tianjin, Tianjin, China
The First Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China
Name: Zhijian Xiao, MD
Affiliation: Tianjin blood research institute
Role: PRINCIPAL_INVESTIGATOR