This is an open-label dose escalation study designed to evaluate the safety and pharmacokinetics of ABBV-085 and determine the recommended Phase 2 dose (as monotherapy or in combination with standard therapies) in subjects with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Administered as an intravenous infusion in 28-day dosing cycles.
Mayo Clinic Arizona /ID# 148582
Phoenix, Arizona, United States
Terminal elimination half life of ABBV-085.
Time frame: UP to 24 months
Maximum observed plasma concentration (Cmax) of ABBV-085.
Time frame: Up to 24 months
Number of participants with Adverse Events
Collect all adverse events at each visit.
Time frame: Up to 24 months
Area under the curve (AUC) from time zero to the last measurable concentration AUC(0-t) of ABBV-085.
AUC (0-t) = Area under the serum concentration curve from time zero (pre-dose) to the time of the last measurable concentration.
Time frame: Up 24 months
Objective response rate (ORR)
ORR is defined as the proportion of the participants who achieve a complete response (CR) or partial response (PR).
Time frame: Up to 24 months
Progression free survival (PFS)
PFS is defined as the time from the first dose date of ABBV-085 to either disease progression or death, whichever occurs first.
Time frame: Up to 24 months
Duration of overall response (DOR)
DOR is defined as the time from the participant's initial CR or PR to the time of disease progression.
Time frame: Up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Scottsdale Healthcare /ID# 151349
Scottsdale, Arizona, United States
University of California, Los Angeles /ID# 148586
Los Angeles, California, United States
Univ of Colorado Cancer Center /ID# 148581
Aurora, Colorado, United States
University of Chicago /ID# 148579
Chicago, Illinois, United States
Dana-Farber Cancer Institute /ID# 143782
Boston, Massachusetts, United States
Washington University-School of Medicine /ID# 151348
St Louis, Missouri, United States
NYU Langone Medical Center /ID# 150786
New York, New York, United States
Duke Univ Med Ctr /ID# 148200
Durham, North Carolina, United States
Carolina BioOncology Institute /ID# 148583
Huntersville, North Carolina, United States
...and 10 more locations