This is an open-label, non-randomized, Phase 1 study to determine the safety and tolerability of NC525. This study will also assess the clinical benefit in subjects with advanced myeloid neoplasms.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Monoclonal antibody specific for LAIR-1
City of Hope
Duarte, California, United States
University of Miami
Miami, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
To Evaluate the Frequency, Duration, and Severity of Treatment-emergent Adverse Events [Safety and Tolerability].
Toxicity grading per NCI CTCAE v5.0.
Time frame: Up to 23 months
To Evaluate Dose-limiting Toxicities (DLTs) of NC525.
Toxicity grading per NCI CTCAE v5.0.
Time frame: Up to 56 days
To Evaluate the Clinical Benefit of NC525 by Assessing Objective Response (OR).
Disease Assessments will be performed using the European Leukemia Net (ELN) Guidelines for the ELN Outcome Measures.
Time frame: Until disease progression, up to 23 months
To Evaluate the Clinical Benefit of NC525 by Assessing Event-free Survival (EFS).
Disease Assessments will be performed using the European Leukemia Net (ELN) Guidelines for the ELN Outcome Measures.
Time frame: Until disease progression, up to 23 months
To Evaluate the Clinical Benefit of NC525 by Assessing Overall Survival (OS).
Disease Assessments will be performed using the European Leukemia Net (ELN) Guidelines for the ELN Outcome Measures.
Time frame: Time until death, up to 23 months
Assessment of Time to Achieve Response, Defined as CR, CRi, or CRh
Disease Assessments will be performed using the European Leukemia Net (ELN) Guidelines for the ELN Outcome Measures.
Time frame: Cycle 1 Day 1 to day remission is achieved, up to 23 months (each cycle is 28 days)
Maximum Observed Serum Concentration (Cmax) of NC525
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Weill Cornell Medicine
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
...and 1 more locations
To evaluate the maximum observed serum concentration (Cmax) of NC525. The values reported are Cmax at Cycle 2 Day 1.
Time frame: During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days)
Terminal Half-life (t1/2) of NC525
To evaluate the Terminal Half-life (t1/2) of NC525.
Time frame: During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days), Cycle 1 reported
Area Under the Serum Concentration Versus Time Curve (AUC) of NC525
To evaluate area under the serum concentration versus time curve (AUC) of NC525
Time frame: During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days), Cycle 1 reported