This is a Phase 1, first-in-human, dose escalation study in participants with advanced solid tumors to determine the pharmacokinetics, maximum tolerated dose and the recommended Phase 2 dose of ABBV-075 at different monotherapy dosing schedules. In addition the study will evaluate the safety. tolerability and the pharmacokinetics of ABBV-075 monotherapy or combination therapy in disease specific expansion cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
ABBV-075 Oral tablets
Venetoclax tablets, film-coated
Scottsdale Healthcare /ID# 132963
Scottsdale, Arizona, United States
City of Hope /ID# 154053
Duarte, California, United States
UC Davis Comp Cancer Ctr /ID# 154644
Sacramento, California, United States
Yale University /ID# 136982
New Haven, Connecticut, United States
University of Chicago /ID# 155453
Chicago, Illinois, United States
Indiana Univ School Medicine /ID# 132946
Indianapolis, Indiana, United States
Duke Univ Med Ctr /ID# 154647
Durham, North Carolina, United States
Mary Crowley Cancer Research /ID# 154059
Dallas, Texas, United States
Univ TX, MD Anderson /ID# 132276
Houston, Texas, United States
UT MD Anderson Cancer Center /ID# 164122
Houston, Texas, United States
Maximum Tolerated Dose of ABBV-075
Maximum tolerated dose is defined as the highest dose level at which less than 2 of 6 participants experience the same dose limiting toxicity. If more than 2 participants experience a different dose limiting toxicity, the maximum tolerated dose may be further evaluated or determined to be exceeded based on discussions with the investigators and medical monitors.
Time frame: Minimum first cycle of dosing (28 days) up to one year for dose escalation segment.
Time to Cmax (peak time, Tmax) for ABBV-075
Time frame: Approximately 24 hours following a single dose of ABBV-075 up to approximately 2 years.
Number of participants with adverse events
Time frame: Screening, Cycle 1 Day 1, 8 and 15, then Day 1 of each cycle up to approximately 2 years.
Maximum observed plasma concentration (Cmax) of ABBV-075
Time frame: Approximately 24 hours following a single dose of ABBV-075 up to approximately 2 years.
Area under the curve (AUC)
Area under the plasma concentration versus time curve from time 0 (pre-dose) to the time of the last measurable concentration (AUC 0-t).
Time frame: Cycle 1 Day 1 Pre-dose, 1, 2, 3, 4, 6, 8 and 24 hours post ABBV-075 dosing, and on Cycle 1 Day 15 at 14, 17, 20 hours post dose.
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: At screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR).
Time frame: At screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.
Progression Free Survival (PFS)
PFS is defined as the time from the first dose of ABBV-075 to either disease progression or death, whichever occurs first.
Time frame: Screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.
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