Clinical Trials List
Protocol NumberD9470C00001
NCT Number(ClinicalTrials.gov Identfier)NCT06179511
Active
2023-12-01 - 2027-11-30
Phase I/II
Recruiting2
A Modular Phase I/II, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of AZD9829 as Monotherapy or in Combination in Patients with CD123-Positive Hematological Malignancies
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 李思慧 Division of Family Medicine
- MING YAO Division of General Internal Medicine
- 田豐銘 Division of General Internal Medicine
- Chien-Chin Lin Division of Others -
- CHENG-HONG TSAI Division of General Internal Medicine
- 林明恩 Division of General Internal Medicine
- - - Division of Hematology & Oncology
- Wen-Chien Chou Division of Others -
- YAO CHI-YUAN Division of Others -
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ya-Ping Chen
- Ya-Ting Hsu
- Sin-Syue Li
- 傅蓓安 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Relapsed/refractory acute myelogenous leukemia, relapsed/refractory high-risk myelodysplastic syndrome
Objectives
• To assess the safety and tolerability of AZD9829 monotherapy or combination therapy in CD123+ hematological malignancies.
• Explore the anti-tumor activity of AZD9829 monotherapy or combination therapy in CD123+ hematological malignancies.
• Characterize the pharmacokinetic (PK) profile of AZD9829 and determine its immunogenicity.
• Assess the pharmacodynamic and biological context relevant to resistance mechanisms.
Test Drug
AZD9829
Active Ingredient
AZD9829
Dosage Form
Lyophiliszed Injection
Dosage
100mg/vial
Endpoints
• Incidence of DLT.
• Incidence, severity, and relationship to IMP of AEs, SAEs, abnormal laboratory assessment results, vital signs, physical examination, and ECG results.
• Incidence, severity, and relationship to IMP of AEs, SAEs, abnormal laboratory assessment results, vital signs, physical examination, and ECG results.
Inclution Criteria
Inclusion Criteria:
-≥18 years of age;
-CD123+ hematologic malignancy based on flow cytometry or immunohistochemistry by local laboratory;
- R/R AML;
-R/R HR-MDS with ≥5% bone marrow blast at time of inclusion;
-Had at least 1 prior line of therapy at currents histology, and have no available treatment options;
-ECOG performance status of ≤ 2.
The above is a summary, other inclusion criteria details may apply.
-≥18 years of age;
-CD123+ hematologic malignancy based on flow cytometry or immunohistochemistry by local laboratory;
- R/R AML;
-R/R HR-MDS with ≥5% bone marrow blast at time of inclusion;
-Had at least 1 prior line of therapy at currents histology, and have no available treatment options;
-ECOG performance status of ≤ 2.
The above is a summary, other inclusion criteria details may apply.
Exclusion Criteria
Exclusion Criteria:
-Active CNS leukemia;
-Previous treatment with any CD123 targeting therapy;
-Prior allogeneic HSCT, within 90 or cell therapy within 60 of start of therapy;
-Active GVHD that requires immunosuppressive treatment within 4 weeks prior to start of AZD9829;
-History of other malignancy(with certain exceptions);
-Active and uncontrolled infections;
-Unresolved AEs ≥2 Grade, from prior therapies.
The above is a summary, other exclusion criteria details may apply.
-Active CNS leukemia;
-Previous treatment with any CD123 targeting therapy;
-Prior allogeneic HSCT, within 90 or cell therapy within 60 of start of therapy;
-Active GVHD that requires immunosuppressive treatment within 4 weeks prior to start of AZD9829;
-History of other malignancy(with certain exceptions);
-Active and uncontrolled infections;
-Unresolved AEs ≥2 Grade, from prior therapies.
The above is a summary, other exclusion criteria details may apply.
The Estimated Number of Participants
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Taiwan
12 participants
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Global
178 participants
