This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-176 for participants with advanced solid tumors likely to express Prolactin Receptor (PRLR). The study will consist of 2 cohorts: Dose Escalation and Expanded Recommended Phase 2 Dose.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Intravenous infusion
HonorHealth Research Institute - Pima /ID# 161078
Scottsdale, Arizona, United States
City of Hope /ID# 161079
Duarte, California, United States
Yale University /ID# 201357
New Haven, Connecticut, United States
Dose Escalation Cohort: Tmax of ABBV-176
Time to Cmax (Tmax) of ABBV-176
Time frame: Up to approximately 57 days
Dose Escalation Cohort: AUC∞ for ABBV-176
AUC∞ is the area under the plasma concentration-time curve from Time 0 to infinite time.
Time frame: Up to approximately 57 days
Dose Escalation Cohort: Terminal phase elimination rate constant (β) for ABBV-176
Terminal phase elimination rate constant (β)
Time frame: Up to approximately 57 days
Dose Escalation Cohort: Recommended Phase 2 dose (RPTD) for ABBV-176
The RPTD will be determined using available safety and pharmacokinetics data upon completion of the Dose Escalation Cohort.
Time frame: Minimum first cycle of dosing (up to 21 days)
Dose Escalation Cohort: Cmax of ABBV-176
Maximum observed plasma concentration (Cmax) of ABBV-176.
Time frame: Up to approximately 57 days
Dose Escalation Cohort: Maximum tolerated dose (MTD) of ABBV-176
MTD will be defined as the highest dose level at which less than or equal to 33% of participants experience a dose limiting toxicity.
Time frame: Minimum first cycle of dosing (up to 21 days)
Expanded Recommended Phase Two Dose (RPTD) Cohort: Objective Response Rate (ORR)
ORR is defined as the proportion of participants with a response of partial response (PR) or better per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Time frame: Up to approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
St. Lukes Cancer Institute /ID# 201353
Kansas City, Missouri, United States
Washington University-School of Medicine /ID# 162745
St Louis, Missouri, United States
Rutgers Cancer Institute of NJ /ID# 161080
New Brunswick, New Jersey, United States
University of Utah /ID# 161606
Salt Lake City, Utah, United States
Sydney Children's Hospital /ID# 162917
Randwick, New South Wales, Australia
Mater Misericordiae /ID# 162918
South Brisbane, Queensland, Australia
Rigshospitalet /ID# 159707
Copenhagen Ø, Capital Region, Denmark
...and 1 more locations
Dose Escalation Cohort: AUCt for ABBV-176
Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCt) for ABBV-176.
Time frame: Up to approximately 57 days
Dose Escalation Cohort: t1/2 for ABBV-176
Terminal elimination half-life (t1/2)
Time frame: Up to approximately 57 days
Expanded RPTD Cohort: AUCt for ABBV-176
Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCt)
Time frame: Up to approximately 15 days
Expanded RPTD Cohort: Tmax of ABBV-176
Time to Cmax (Tmax) of ABBV-176
Time frame: Up to approximately 15 days
Expanded RPTD Cohort: Overall Survival (OS)
OS is defined as number of days from the date of the first dose to the date of death for all dosed subjects. For subjects who are not deceased, the data will be censored at the date of the last study visit, or the last know date to be alive, whichever is later.
Time frame: Up to 2 years after the last dose of study drug
Expanded RPTD Cohort: Cmax of ABBV-176
Maximum observed plasma concentration (Cmax) of ABBV-176.
Time frame: Up to approximately 15 days
Expanded RPTD Cohort: Duration of Response (DOR)
DOR is defined as the time from the date of the participant's documented first response of PR or better to the date of documented disease progression or death due to the disease, whichever occurs first.
Time frame: Up to approximately 2 years
Expanded RPTD Cohort: Terminal phase elimination rate constant (β) for ABBV-176
Terminal phase elimination rate constant (β) for ABBV-176
Time frame: Up to approximately 15 days
Expanded Recommended Phase Two Dose (RPTD) Cohort: Progression-Free Survival (PFS)
PFS is defined as the time from the participant's first dose of study drug (Day 1) to the date of documented disease progression (per RECIST 1.1), or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Expanded RPTD Cohort: Change in ECOG Performance Status
Change from baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: Up to approximately 2 years
Expanded RPTD Cohort: AUC∞ for ABBV-176
Area Under the Plasma Concentration-time Curve from Time 0 to infinite time (AUC∞)
Time frame: Up to approximately 15 days
Expanded RPTD Cohort: t1/2 for ABBV-176
Terminal elimination half-life (t1/2) for ABBV-176
Time frame: Up to approximately 15 days
Dose Escalation Cohort: Change from Baseline in QTcF
QT interval measurement corrected by Fridericia's formula (QTcF) mean change from baseline
Time frame: Up to approximately 47 days