This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
HonorHealth Research Institute - Pima /ID# 155461
Scottsdale, Arizona, United States
UC Davis Comprehensive Cancer Center - Main /ID# 154439
Sacramento, California, United States
Number of participants with adverse events
Time frame: First dose of study drug through at least 100 days after end of treatment; up to 2 years after last participants first dose
Recommended Phase 2 Dose (RPTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab
If a maximum tolerated dose (MTD) is reached, the RPTD of ABBV-428 will not be a dose higher than the defined MTD, and will be selected based on the type(s) and occurrence(s) of dose limiting toxicities which occur in addition to the MTD. If a MTD is not reached, then the RPTD will be defined based on the safety and pharmacokinetic data.
Time frame: 1 day of study drug administration within the 28-day cycle at the designated cohort dose
Area under the serum concentration-time curve (AUC) of ABBV-428
Time frame: Up to 30 days after a 24-month treatment period
Terminal half-life (t1/2) of ABBV-428
Time frame: Up to 30 days after a 24-month treatment period
Maximum observed serum concentration (Cmax) of ABBV-428
Time frame: Up to 30 days after a 24-month treatment period
Maximum tolerated dose (MTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab
The highest dose level at which less than 2 of 6 participants or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity.
Time frame: Up to 2 years
Time to Cmax (Tmax) of ABBV-428
Time frame: Up to 30 days after a 24-month treatment period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Chicago /ID# 154440
Chicago, Illinois, United States
Fox Chase Cancer Center /ID# 170665
Philadelphia, Pennsylvania, United States
Greenville Hospital System /ID# 154437
Greenville, South Carolina, United States
MD Anderson Cancer Center at Texas Medical Center /ID# 154441
Houston, Texas, United States
South Texas Accelerated Research Therapeutics /ID# 154442
San Antonio, Texas, United States
Chris O'Brien Lifehouse /ID# 163131
Camperdown, New South Wales, Australia
Northern Cancer Institute /ID# 163132
St Leonards, New South Wales, Australia
Institut Bergonie /ID# 202391
Bordeaux, Gironde, France
...and 5 more locations
Duration of Objective Response (DOR)
DOR defined as the time from the initial objective response to disease progression or death, whichever occurs first.
Time frame: Up to 30 days after a 24-month of treatment period
Clinical benefit rate (CBR)
CBR defined as the proportion of subjects with a confirmed partial response (PR), complete response (CR), or stable disease for at least 24 weeks to the treatment.
Time frame: Up to 30 days after a 24-month of treatment period
Progression-Free Survival (PFS)
PFS time is defined as the time from the first dose of ABBV-428 to disease progression or death, whichever occurs first
Time frame: Up to 30 days after a 24-month of treatment period
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects with a confirmed partial or complete response to the treatment.
Time frame: Up to 30 days after a 24-month of treatment period