This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 in participants with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
163
The Angeles Clinic and Researc /ID# 156324
Los Angeles, California, United States
Maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181
The MTD and the RPTD of ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 will be determined during the dose escalation phase of the study. Once the RPTD has been determined, the dose expansion portion will begin.
Time frame: Up to 8 weeks
Time to Cmax (Tmax) of ABBV-927
Time to Cmax (Tmax) of ABBV-927.
Time frame: Up to 12 weeks after participant's first dose
Maximum observed serum concentration (Cmax) of ABBV-927
Maximum observed serum concentration (Cmax) of ABBV-927.
Time frame: Up to 12 weeks after participant's first dose
Terminal-Phase Elimination Rate Constant (β) of ABBV-927
Terminal-phase elimination rate constant (β)of ABBV-927.
Time frame: Up to 12 weeks after participant's first dose
Terminal half-life (t1/2) of ABBV-927
Terminal half-life (t1/2) of ABBV-927.
Time frame: Up to 4 weeks after participant's first dose
Area under the serum concentration-time curve (AUCt) of ABBV-927
Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) of ABBV-927.
Time frame: Up to 12 weeks after participant's first dose
Time to Cmax (Tmax) of ABBV-181
Time to Cmax (Tmax) of ABBV-181.
Time frame: Up to 12 weeks after participant's first dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The University of Chicago Medical Center /ID# 155264
Chicago, Illinois, United States
Massachusetts General Hospital /ID# 155267
Boston, Massachusetts, United States
Carolina BioOncology Institute /ID# 155265
Huntersville, North Carolina, United States
Tennessee Oncology-Nashville Centennial /ID# 158654
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center /ID# 155263
Houston, Texas, United States
Virginia Cancer Specialists - Fairfax /ID# 155266
Fairfax, Virginia, United States
Peninsula Oncology Centre /ID# 164372
Frankston, Victoria, Australia
Austin Health /ID# 171189
Heidelberg, Victoria, Australia
University Health Network_Princess Margaret Cancer Centre /ID# 200819
Toronto, Ontario, Canada
...and 12 more locations
Maximum observed serum concentration (Cmax) of ABBV-181
Maximum observed serum concentration (Cmax) of ABBV-181.
Time frame: Up to 12 weeks after participant's first dose
Terminal-Phase Elimination Rate Constant (β) of ABBV-181
Terminal-phase elimination rate constant (β)of ABBV-181.
Time frame: Up to 12 weeks after participant's first dose
Terminal half-life (t1/2) of ABBV-181
Terminal half-life (t1/2) of ABBV-181.
Time frame: Up to 4 weeks after participant's first dose
Area under the serum concentration-time curve (AUCt) of ABBV-181
Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) of ABBV-181.
Time frame: Up to 12 weeks after participant's first dose
Number of Participants with Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to 30 days after and up to 24-month of treatment period
Clinical benefit rate (CBR, defined as the percentage of participants with a confirmed partial, complete response, or stable disease for at least 24 weeks to the treatment)
CBR defined as the proportion of subjects with a confirmed partial response (PR), complete response (CR), or stable disease for at least 24 weeks to the treatment.
Time frame: Up to 30 days after and up to 24-month of treatment period
Duration of objective response (DOR)
DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.
Time frame: Up to 30 days after and up to 24-month of treatment period
Objective response rate (ORR)
ORR is defined as the proportion of participants with a confirmed partial or complete response to the treatment.
Time frame: Up to 30 days after and up to 24-month of treatment period
Progression-free survival (PFS)
PFS time is defined as the time from the first dose of ABBV-927 to disease progression or death, whichever occurs first.
Time frame: Up to 30 days after and up to 24-month of treatment period