A Phase 1 interventional study of ABBV-927 and Budiglimab in Pancreatic Cancer, sponsored by AbbVie. Terminated at 15 sites in 6 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-07.
Sponsored by AbbVie · Phase 1, Interventional, and Treatment
Metastatic Pancreatic Cancer Disease is one of the most aggressive and deadliest forms of cancer with very poor survival. This study will evaluate adverse events and change in disease activity in participants 18 to 75 years of age with a body weight greater than or equal to 35 kg with Metastatic Pancreatic Cancer Disease treated with Intravenous (IV) infusion of modified FOLFIRINOX (mFFX) combined with IV infusions of ABBV-927 with or without Budigalimab.
ABBV-927 and Budigalimab are the investigational drugs being developed for treatment of Metastatic Pancreatic Cancer Disease. In this study, doctors will enroll participants between 18 and 75 years of age with a body weight greater than or equal to 35 kg diagnosed diagnosed with Metastatic Pancreatic Cancer Disease in 4 different groups, called treatment arms. Each group will receive different treatments. Approximately 129 adult participants will be enrolled in the study across approximately 27 sites worldwide.
Participants will receive ABBV-927 and Budigalimab as Intravenous (IV) Infusion in Phase 1b on day 3 of every 28 day cycle, modified FOLFIRINOX as IV Infusion in Phase 1b on Day1 and Day 15 of every 28 day cycle up to maximum of 2 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study study was terminated before the Phase 2 portion of the study began.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 40 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive escalating doses of ABBV-927 in combination with modified FOLFIRINOX (mFFX) and Budigalimab.
Drug: ABBV-927 · Drug: Budiglimab · Drug: modified FOLFIRINOX
Intravenous (IV) Infusion
Intravenous (IV) Infusion
Also known as: ABBV-181
Intravenous (IV) Infusion
Also known as: mFFX
Phase 1b: Percentage of participants experiencing Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.
Time frame: Up to 6 months
Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Laboratory (Hematological and Chemistry) Values
Baseline values and changes from baseline will be summarized for each scheduled post-baseline visit for laboratory data as applicable. If more than one measurement exists for a participant on a particular day and time, an arithmetic average will be calculated. This average will be that participant's measurement for that day. For participants that do not have any post-baseline measurements, only their baseline values will be summarized.
Time frame: Up to 6 months
Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Vital Signs
Baseline values and changes from baseline will be summarized for each scheduled post-baseline visit for vital signs data.
Time frame: Up to 6 months
Phase 1b: Number of Participants with Dose Limiting Toxicities (DLT)
A DLT is defined as any serious AE for which a clear alternative cause cannot be established (e.g., attributed to the disease under study, another disease, or to a concomitant medication \[e.g., COVID-19 vaccine\] by the investigator or AbbVie Therapeutic Area (TA) MD\] that occurs during the DLT observation period, and is not listed as a predefined exception in the protocol.
Time frame: Up to 6 months
Phase 1b: Maximum Plasma Concentration (Cmax)
The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval.
Time frame: Up to approximately 3 months
Phase 1b: Time to Maximum Observed Plasma Concentration (Tmax)
The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax.
Time frame: Up to approximately 3 months
Phase 1b: Area Under the Concentration-time Curve Over the Time Interval (AUC) in Plasma
The area under the plasma concentration-time curve (AUC; measured in ng\*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma.
Time frame: Up to approximately 3 months.
Phase 1b: Objective Response Rate (ORR)
ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) per investigator assessment according to RECIST version 1.1.
Time frame: Up to approximately 27 months
Phase 1b: Clinical Benefit Rate (CBR)
Clinical Benefit Rate (CBR) is defined as the percentage of participants whose best overall response is either Complete Response (CR), Partial Response (PR), or stable disease (SD) according to RECIST version 1.1.
Time frame: Up to approximately 27 months
Phase 1b: Duration of Response (DOR) for Participants Who Achieve a Documented Confirmed Response of CR/PR
DOR is defined as the time from the initial response of CR/PR per investigator review according to RECIST version 1.1 criteria to the first occurrence of radiographic disease progression, clinical progression or death from any cause whichever occurs first.
Time frame: Up to approximately 27 months
Phase 1b: Progression Free Survival (PFS)
PFS is defined as the time from randomization to a documented radiographic disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, clinical progression or death from any cause, whichever occurs earlier.
Time frame: Up to approximately 24 months after study drug discontinuation
Phase 1b: Quality of Life(QoL)-Measure Participant Overall Perceptions of Their Change in Pancreatic Cancer Symptoms includes the Patient Global Impression of Severity (PGIS) and the the Patient Global Impression of Change (PGIC)
Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) will measure participants' overall perceptions of their pancreatic cancer symptoms over time.
Time frame: Up to approximately 25 months
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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