The study will determine the recommended Phase 2 dose (RP2D) of livmoniplimab (ABBV-151) administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of livmoniplimab alone and in combination with budigalimab. The study will consist of 2 parts: dose escalation and dose expansion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
364
Liquid for intravenous infusion.
Lyophilized powder for solution for intravenous infusion.
Highlands Oncology Group, PA /ID# 218942
Springdale, Arkansas, United States
City of Hope National Medical Center /ID# 265620
Duarte, California, United States
City of Hope Orange County Lennar Foundation Cancer Center /ID# 270785
Irvine, California, United States
Yale University School of Medicine /ID# 208356
New Haven, Connecticut, United States
AdventHealth Celebration /ID# 224860
Celebration, Florida, United States
Dose Escalation: Recommended Phase 2 Dose (RP2D) Livmoniplimab Monotherapy
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation portion of the study.
Time frame: Up to 28 days after the first dose of Livmoniplimab monotherapy
Dose Escalation: RP2D Livmoniplimab + Budigalimab Combination Therapy
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamic (PD) data collected during the dose escalation portion of the study.
Time frame: Up to 28 days after the first dose of Livmoniplimab and Budigalimab combination therapy
Dose Expansion: Objective Response Rate (ORR)
ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Up to approximately 6 months after the first dose date of last participant in Dose Expansion
Dose Expansion: Duration of Response (DOR)
The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.
Time frame: Up to approximately 6 months after the first dose date of last participant in Dose Expansion
Dose Expansion: Progression-free Survival (PFS)
Progression-free survival is defined as the time from the participant's first dose of study treatment (livmoniplimab or budigalimab) to the first date of either disease progression or death, whichever occurs first.
Time frame: Up to approximately 6 months after the first dose date of last participant in Dose Expansion
Maximum Observed Serum Concentration (Cmax) of Livmoniplimab
Maximum Serum Concentration (Cmax) of livmoniplimab.
Time frame: Up to approximately 70 days after initial dose of study drug
Time to Maximum Observed Serum Concentration (Tmax) of Livmoniplimab
Time to maximum serum concentration (Tmax) of livmoniplimab.
Time frame: Up to approximately 70 days after initial dose of study drug
Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCτ) of Livmoniplimab
Area under the serum concentration-time curve from time 0 to the time of the last measurable concentration (AUCτ) of livmoniplimab.
Time frame: Up to approximately 70 days after initial dose of study drug
Terminal-phase Elimination Rate Constant (β) of Livmoniplimab
Apparent terminal phase elimination rate constant (β or Beta) of livmoniplimab.
Time frame: Up to approximately 70 days after initial dose of study drug
Terminal Phase Elimination Half-life (t1/2) of Livmoniplimab
Terminal phase elimination half-life (t1/2) of livmoniplimab.
Time frame: Up to approximately 70 days after initial dose of study drug
Maximum Observed Serum Concentration (Cmax) of Budigalimab
Maximum Serum Concentration (Cmax) of budigalimab.
Time frame: Up to approximately 70 days after initial dose of study drug
Time to Maximum Observed Serum Concentration (Tmax) of Budigalimab
Time to maximum serum concentration (Tmax) of budigalimab.
Time frame: Up to approximately 70 days after initial dose of study drug
Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCτ) of Budigalimab
Area under the serum concentration-time curve from time 0 to the time of the last measurable concentration (AUCτ) of budigalimab.
Time frame: Up to approximately 70 days after initial dose of study drug
Terminal-phase Elimination Rate Constant (β) of Budigalimab
Apparent terminal phase elimination rate constant (β or Beta) of budigalimab.
Time frame: Up to approximately 70 days after initial dose of study drug
Terminal Phase Elimination Half-life (t1/2) of Budigalimab
Terminal phase elimination half-life (t1/2) of budigalimab.
Time frame: Up to approximately 70 days after initial dose of study drug
Number of Participants With Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Time frame: Up to approximately 9 months after the first dose date of last participant
Change in Vital Signs
Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.
Time frame: Up to approximately 6 months after the first dose date of last participant
Change in Laboratory Parameters
Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.
Time frame: Up to approximately 6 months after the first dose date of last participant
Change in Electrocardiogram (ECG)
12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
Time frame: Up to approximately 6 months after the first dose date of last participant
Incidence of Anti-drug Antibody (ADA)
The number of participants with anti-drug antibodies.
Time frame: Up to approximately 6 months after the first dose date of last participant
Dose Expansion Cohorts 10 to 12: Overall Survival (OS)
OS is defined as time from first study treatment to death due to any cause.
Time frame: Up to approximately 6 months after the first dose date of last participant in Cohorts 10 to 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Duplicate_AdventHealth Cancer Institute - Orlando /ID# 226953
Orlando, Florida, United States
Indiana Univ School Medicine /ID# 208384
Indianapolis, Indiana, United States
Community Health Network, Inc. /ID# 257032
Indianapolis, Indiana, United States
Univ Michigan Med Ctr /ID# 221129
Ann Arbor, Michigan, United States
Washington University-School of Medicine /ID# 259684
St Louis, Missouri, United States
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