ABBV-428
DrugABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.
NCT Number: NCT02955251
This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.
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Notify Me18 year–99 year
All sexes
Interventional
Phase 1
Chris O'Brien Lifehouse /ID# 163131, Camperdown, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.
Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules.
Other names: OPDIVO
Time frame: First dose of study drug through at least 100 days after end of treatment; up to 2 years after last participants first dose
Time frame: 1 day of study drug administration within the 28-day cycle at the designated cohort dose
If a maximum tolerated dose (MTD) is reached, the RPTD of ABBV-428 will not be a dose higher than the defined MTD, and will be selected based on the type(s) and occurrence(s) of dose limiting toxicities which occur in addition to the MTD. If a MTD is not reached, then the RPTD will be defined based on the safety and pharmacokinetic data.
Time frame: Up to 30 days after a 24-month treatment period
Time frame: Up to 30 days after a 24-month treatment period
Time frame: Up to 30 days after a 24-month treatment period
Time frame: Up to 2 years
The highest dose level at which less than 2 of 6 participants or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity.
Time frame: Up to 30 days after a 24-month treatment period
Time frame: Up to 30 days after a 24-month of treatment period
DOR defined as the time from the initial objective response to disease progression or death, whichever occurs first.
Time frame: Up to 30 days after a 24-month of treatment period
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 a 24-month of treatment period
PFS time is defined as the time from the first dose of ABBV-428 to disease progression or death, whichever occurs first
Time frame: Up to 30 days after a 24-month of treatment period
ORR is defined as the proportion of subjects with a confirmed partial or complete response to the treatment.
AbbVie
Industry
A Multi-Center, Phase 1, Open-Label, Dose-Escalation Study of ABBV-428, an Immunotherapy in Subjects With Advanced Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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