A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 with ABBV-368, Budigalimab (ABBV-181) and/or chemotherapy in participants with selected solid tumors. This study consists of 2 main parts, a dose-escalation phase and a dose-expansion phase. The dose-expansion phase can begin once the recommended phase 2 dose/maximum tolerated dose (RP2D/MTD) is determined in the dose-escalation phase.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Intravenous (IV) Infusion
Intravenous (IV) Infusion
Intravenous (IV) Infusion
Intravenous (IV) Infusion
Intravenous (IV) Infusion
Highlands Oncology Group, PA /ID# 218863
Springdale, Arkansas, United States
St Jude Hospital dba St Joseph /ID# 211130
Santa Rosa, California, United States
Yale University School of Medicine /ID# 210678
New Haven, Connecticut, United States
Moffitt Cancer Center /ID# 215037
Tampa, Florida, United States
Fort Wayne Medical Oncology and Hematology, Inc /ID# 226072
Fort Wayne, Indiana, United States
Dose Expansion: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with either complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Up to approximately 2 years following the first dose of study drug
Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368
The RP2D of ABBV-927 + ABBV-368 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics data.
Time frame: Up to approximately 6 months
Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181
The RP2D of ABBV-927 + ABBV-368 + ABBV-181 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics data.
Time frame: Up to approximately 6 months
Dose-Expansion Phase: Progression-free Survival (PFS)
PFS is defined as the time from date of first study drug exposure to disease progression or death, whichever occurs first.
Time frame: Up to approximately 2 years since the first dose of study drug
Dose-Expansion Phase: Duration of Response (DOR)
DOR defined as the time from the participant's initial response to study drug therapy to disease progression or death, whichever occurs first.
Time frame: Up to approximately 2 years since the first dose of study drug
Maximum Serum Concentration (Cmax)
Maximum Serum Concentration (Cmax)
Time frame: Up to approximately 12 weeks after participant's initial dose of study drug
Time to Maximum Observed Serum Concentration (Tmax)
Time to Maximum Observed Serum Concentration (Tmax)
Time frame: Up to approximately 12 weeks after participant's initial dose of study drug
Area Under the Serum Concentration Versus Time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCτ)
Area under the serum concentration versus time curve from time 0 to the time of the last measurable concentration (AUCτ).
Time frame: Up to approximately 12 weeks after participant's initial dose of study drug
Terminal Phase Elimination Half-life (t1/2)
Terminal Phase Elimination Half-life (t1/2)
Time frame: Up to approximately 4 weeks after participant's initial dose of study drug
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Washington University-School of Medicine /ID# 221399
St Louis, Missouri, United States
Duke Cancer Center /ID# 217641
Durham, North Carolina, United States
Carolina BioOncology Institute /ID# 210664
Huntersville, North Carolina, United States
UPMC Hillman Cancer Ctr /ID# 222747
Pittsburgh, Pennsylvania, United States
Tennessee Oncology-Nashville Centennial /ID# 221400
Nashville, Tennessee, United States
...and 16 more locations