Status:
TERMINATED
A Study to Evaluating the Pharmacokinetics, Safety, and Efficacy of ATG 016 Monotherapy in IPSS-R Intermediate Risk and Above Myelodysplastic Syndrome (MDS)
Lead Sponsor:
Shanghai Antengene Corporation Limited
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 aft...
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 aft...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04691141
Start Date
February 23 2021
End Date
September 19 2023
Last Update
April 17 2024
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
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 Municipality, China, 201306