The primary purpose of Phase 1 is to characterize the safety and tolerability to identify the recommended dose (RD) of Debio 1562M for further development. The primary objective of Phase 2 is to evaluate the antileukemic activity of Debio 1562M.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
Administered as intravenous (IV) infusion
City of Hope Comprehensive Cancer Center
Duarte, California, United States
RECRUITINGMoffitt Cancer Center and Research Institute Hospital
Tampa, Florida, United States
RECRUITINGUniversity of Chicago
Chicago, Illinois, United States
Phase 1 (Dose Escalation): Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Time frame: Up to Day 28
Phase 1: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to Day 219
Phase 1 (Dose Optimization): Recommended Dose (RD) of Debio 1562M
Time frame: Up to Day 198
Phase 2: Percentage of Participants With Complete Remission (CR) + CR with partial hematological recovery (CRh)
Time frame: Up to Day 198
Phases 1 and 2: Overall Response (OR)
Time frame: Up to Day 198
Phases 1 and 2: Percentage of Participants with CR
Time frame: Up to Day 198
Phase 1: Percentage of Participants With CR+ CRh
Time frame: Up to Day 198
Phases 1 and 2: Percentage of Participants With Composite Complete Remission (cCR)
Time frame: Up to Day 198
Phases 1 and 2: Percentage of Participants With Allogeneic Hematopoietic Stem Cell Transplant (ASCT)
Time frame: Up to Day 198
Phases 1 and 2: Change From Baseline in Blood Blast Count
Time frame: Baseline upto Day 198
Phases 1 and 2: Duration of Remission (DOR)
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START Midwest
Grand Rapids, Michigan, United States
RECRUITINGRoswell Park Comprehensive Cancer Center
Buffalo, New York, United States
RECRUITINGThe Ohio Sate University
Columbus, Ohio, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGTime frame: Up to Day 198
Phases 1 and 2: Relapse Free Survival (RFS)
Time frame: Up to Day 198
Phase 1 (Dose Optimization) and Phase 2: Event Free Survival (EFS)
Time frame: Up to Day 198
Phase 1 (Dose Optimization) and Phase 2: Overall Survival (OS)
Time frame: Up to Day 198
Phases 1 and 2: Plasma Concentration of Debio 1562M and its Metabolites
Time frame: Pre-dose and at multiple time points up to Day 198
Phase 1 (Dose Optimization) and Phase 2: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to Day 219