The primary purpose of this study is to assess the safety and tolerability of AB598 in participants with advanced malignancies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Mayo Clinic Arizona
Phoenix, Arizona, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Lake City Cancer Care, LLC.
Lake City, Florida, United States
Affinity Health Hope and Healing Cancer Services, LLC
Hinsdale, Illinois, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Gabrail Cancer Center (GCC) Canton Facility
Canton, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Next Oncology Dallas
Irving, Texas, United States
...and 5 more locations
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 2 years
Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: Up to 2 years
Area Under the Concentration-Time Curve from Administration ("0") to the Time That the Drug is No Longer Present in the Body ("infinity") (AUC 0-inf) in Whole Blood and Plasma
Time frame: Predose, Up to 4 hours post dose
Maximum Concentration (Cmax) in Whole Blood and Plasma
Time frame: Predose, Up to 4 hours post dose
Time to Maximum Concentration (Tmax) in Whole Blood and Plasma
Time frame: Predose, Up to 4 hours post dose
Number of Participants Who Test Positive for Antidrug Antibodies (ADAs) to AB598
Time frame: Up to 2 years
Objective Response Rate (ORR)
Time frame: Up to 2 years
Dose Expansion Cohort: Duration of Response (DOR)
Time frame: Up to 2 years
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