An open-label, dose-escalation (Part 1), dose-expansion (Part 2) study to assess the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-155 alone and in combination with paclitaxel or docetaxel. In Part 1 (dose escalation), participants will receive escalating doses of ABBV-155 monotherapy (Part 1a) or ABBV-155 in combination with paclitaxel or docetaxel (Part 1b). In Part 2 (dose expansion), participants will receive ABBV-155 monotherapy or in combination therapy. The ABBV-155 monotherapy cohort will enroll participants with relapsed or refractory (R/R) small cell lung cancer (SCLC) (Part 2a); the ABBV-155 plus a taxane (paclitaxel or docetaxel) combination cohort will enroll participants with R/R non-small cell lung cancer (NSCLC) and breast cancer (Part 2b).
The Escalation cohorts (Part 1) have been completed. The expansion cohorts (Part 2) are open to enrollment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
168
Intravenous (IV) Infusion
Intravenous (IV) Infusion
Intravenous (IV) Infusion
University of Alabama at Birmingham - Main /ID# 214024
Birmingham, Alabama, United States
Highlands Oncology Group, PA /ID# 201568
Springdale, Arkansas, United States
UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 206105
Orange, California, United States
Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 204267
West Hollywood, California, United States
Univ of Colorado Cancer Center /ID# 208365
Aurora, Colorado, United States
MTD and/or RPTD of ABBV-155
The Maximum Tolerated Dose (MTD) and/or the Recommended Phase Two Dose (RPTD) of ABBV-155 will be determined during the dose escalation phase (Part 1).
Time frame: Up to approximately 21 days after initial dose of study drug
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with documented best response partial response (PR) or better according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Up to approximately 2 to 6 months
Number of Participants with Adverse Events (AE)
An AE is defined as any untoward medical occurrence in a subject or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to approximately 12 months
Duration of Response (DOR)
DOR is defined as the number of days from the date of first documented response (PR or better) to the date of the first documented disease progression (PD) or death due to disease, whichever occurs first.
Time frame: Up to approximately 12 months
Rate of Complete Response (CR)
CR is defined as the percentage of participants with documented best response CR according to RECIST version 1.1
Time frame: Up to approximately 2 to 6 months
Progression-Free Survival (PFS)
PFS is defined as the number of days from the date of first dose of study drug to the date of the first documented PD or death due to any cause, whichever occurs first.
Time frame: Up to approximately 12 months
Overall Survival (OS)
OS is defined as the number of days from the date of first study drug to the date of death due to any cause.
Time frame: Up to approximately 12 months after last dose of study drug
Cmax of ABBV-155
Maximum plasma concentration (Cmax).
Time frame: Up to approximately 48 days
Tmax of ABBV-155
Time to maximum plasma concentration (Tmax).
Time frame: Up to approximately 48 days
Terminal Phase Elimination Rate constant of ABBV-155
Terminal phase elimination rate constant of ABBV-155
Time frame: Up to approximately 48 days
AUCt of ABBV-155
Area under the plasma concentration versus time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt).
Time frame: Up to approximately 48 days
AUCinf of ABBV-155
AUC from time 0 to infinite time (AUCinf).
Time frame: Up to approximately 48 days
QTcF Change from Baseline
QT interval measurement corrected by Fridericia's formula (QTcF) mean change from baseline by dose level of ABBV-155 Monotherapy.
Time frame: Up to approximately 8 days
t1/2 of ABBV-155
Terminal elimination half-life (t1/2).
Time frame: Up to approximately 48 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Yale University, Yale Cancer Center /ID# 201542
New Haven, Connecticut, United States
AdventHealth Orlando /ID# 227242
Orlando, Florida, United States
Northwestern University Feinberg School of Medicine /ID# 201563
Chicago, Illinois, United States
Duplicate_Johns Hopkins Bayview Med Cnt /ID# 215095
Baltimore, Maryland, United States
Johns Hopkins Hospital /ID# 201320
Baltimore, Maryland, United States
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