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Folfirinox

Participants will receive escalating doses of ABBV-927 in combination with modified FOLFIRINOX (mFFX) and Budigalimab.

Participants will receive modified FOLFIRINOX on Day 1 and Day 15 of each 28 day cycle.

Participants will receive modified FOLFIRINOX (Day 1 and Day 15) + ABBV-927 in each 28 day cycle.

Participants will receive modified FOLFIRINOX (Day 1 and Day 15) + ABBV 927 and Budigalimab as Intravenous (IV) Infusion in each 28 day cycle.

ABBV-927

Budiglimab

modified FOLFIRINOX

ABBVIE INC.

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 and Phase 2 on day 3 of every 28 day cycle, modified FOLFIRINOX as IV Infusion in Phase 1b and Phase 2 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 to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 is Administered in Combination With IV Modified FOLFIRINOX (mFFX) With or Without IV Budigalimab Compared to mFFX in Adult Participants With Untreated Pancreatic Cancer Metastasis

A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination With Modified FOLFIRINOX (mFFX) With or Without Budigalimab Compared to mFFX in Subjects With Untreated Metastatic Pancreatic Adenocarcinoma

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.

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.

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.

Baseline values and changes from baseline will be summarized for each scheduled post-baseline visit for vital signs data.

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.

Overall survival is defined as the time between the date of randomization and death due to any cause.

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.

The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax.

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.

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.

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.

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.

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.

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.

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.

Spots Global Cancer Trial Database for modified folfirinox (mffx)