The primary purpose of this study is to assess the safety and tolerability of AB801 in participants with advanced malignancies, and to determine a recommended AB801 dose for expansion.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
91
Research Site
Denver, Colorado, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Grand Rapids, Michigan, United States
Number of Participants With Adverse Events
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 Plasma Drug Concentration-Time Curve (AUC)
Time frame: Predose, Up to 8 hours postdose
Maximum Concentration (Cmax) in Plasma
Time frame: Predose, Up to 8 hours postdose
Time to Maximum Concentration (Tmax) in Plasma
Time frame: Predose, Up to 8 hours postdose
Objective response rate (ORR) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 2 years
Dose Expansion Cohorts: Duration of Response (DOR) as Assessed per RECIST v1.1
Time frame: Up to 2 years
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Research Site
New York, New York, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Dallas, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
West Valley City, Utah, United States
Research Site
Fairfax, Virginia, United States