The purpose of this study is to determine the recommended Phase 2 dose and evaluate safety profile of cusatuzumab in combination with azacitidine in Japanese participants with treatment naïve acute myeloid leukemia (AML) who are not candidates for intensive treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Cusatuzumab at a dose 20 milligram per kilogram (mg/kg) once every 2 weeks will be administered intravenously.
Azacitidine at a dose 75 milligram per square meters (mg/m\^2) will be administered subcutaneously or intravenously.
Fukushima Medical University Hospital
Fukushima, Japan
Gunmaken Saiseikai Maebashi Hospital
Maebashi, Japan
Osaka City General Hospital
Osaka, Japan
NTT Medical Center Tokyo
Tokyo, Japan
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs will be reported.
Time frame: Up to 3 years
Part 1 and Part 2: Number of Participants with Dose-Limiting Toxicity (DLTs)
Number of participants with DLTs will be reported.
Time frame: Up to 42 days
Part 1 and Part 2: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Severity of DLT as assessed by NCI-CTCAE in participants will be reported.
Time frame: Up to 42 days
Part 1 and Part 2: Percentage of Participants with Complete Response (CR)
Percentage of participants with complete response based on response criteria per investigator assessment in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) will be reported.
Time frame: Up to 9 months
Part 1: Objective Response Rate (ORR)
ORR is defined as percentage of participants with CR, CRh and CRi based on response criteria per investigator assessment in participants with AML.
Time frame: Up to 6 months
Part 2: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with CR, partial response (PR) and marrow CR based on response criteria per investigator assessment in participants with MDS.
Time frame: Up to 9 months
Part 2: Percentage of Participants with Hematologic Improvement (HI)
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University of Fukui Hospital
Yoshida, Japan
Percentage of participants with hematologic improvement will be reported according to response criteria per investigator assessment in participants with MDS.
Time frame: Up to 9 months
Part 1 and Part 2: Time to Response
Time to response is defined as time from first dose to achieving the first response of CR, CRh, or CRi in participants with AML and CR, PR or marrow CR in participants with MDS..
Time frame: Up to 3 years
Part 1 and Part 2: Duration of Response
Duration of response is defined as time from achieving the first response of CR, CRh, or CRi in participants with AML and CR, PR or marrow CR in participants with MDS to hematologic relapse or death of any cause.
Time frame: Up to 3 years
Part 1 and Part 2: Red Blood Cell (RBC) or Platelets Transfusion Independence
Transfusion independence (RBC or platelets) is defined as a period of at least 56 consecutive days with no transfusion between first dose of study drug and the last dose of study drug +30 days.
Time frame: Up to 3 years
Part 1 and Part 2: Overall Survival (OS)
OS is defined as the time from initial study intervention administration to death from any cause.
Time frame: Up to 3 years
Part 1 and Part 2: Maximum Serum Concentration (Cmax) of Cusatuzumab
Cmax is the maximum observed serum concentration.
Time frame: Up to 3 years
Part 1 and Part 2: Serum Trough Concentration (Ctrough) of Cusatuzumab
Ctrough is the serum concentration immediately prior to the next drug administration.
Time frame: Up to 3 years