ABBV-927
DrugIntravenous (IV) Infusion
NCT Number: NCT03893955
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1
Duplicate_Icon Cancer Centre /ID# 224084, South Brisbane, Queensland, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Dose-Escalation:
Dose-Expansion:
Exclusion criteria
Intravenous (IV) Infusion
Intravenous (IV) Infusion
Intravenous (IV) Infusion
Other names: Budigalimab
Intravenous (IV) Infusion
Intravenous (IV) Infusion
Time frame: Up to approximately 2 years following the first dose of study drug
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 6 months
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
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 2 years since the first dose of study drug
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
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 12 weeks after participant's initial dose of study drug
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 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).
Time frame: Up to approximately 4 weeks after participant's initial dose of study drug
Terminal Phase Elimination Half-life (t1/2)
AbbVie
Industry
A Phase 1, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Combinations of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Subjects With Locally Advanced or Metastatic 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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