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

Stopped early · Phase 1

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT04807972

Run by

AbbVie

People needed

40

Starts

2021-05-28

Expected to finish

2024-03-25

Last updated by the study team

2025-01-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body weight >= 35 kg.
• Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with metastatic disease.
• Measurable disease per Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1).
• Prior history of or clinically stable concurrent malignancy are eligible for enrollment provided the malignancy is clinically insignificant, no treatment is required, and the participant is clinically stable.

You may not qualify if…

• Participants with locally advanced disease.
• Participants with neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.
• Prior radiotherapy, surgery, or systemic anti-cancer therapy for the treatment of metastatic pancreatic adenocarcinoma.
• Prior radiotherapy, surgery, or systemic anti-cancer therapy in the adjuvant setting, or earlier, within the last 4 months.
• Prior radiotherapy to any measurable metastatic lesion at any time.
• Clinically significant third-space fluid accumulation (e.g., ascites or pleural effusion).
• Known metastases to the central nervous system (CNS).

Where it is running

• UCHSC Anschultz Cancer Pavilion /ID# 227841 — Aurora, Colorado, United States
• Johns Hopkins Hospital /ID# 226713 — Baltimore, Maryland, United States
• Univ Hosp Cleveland /ID# 226807 — Cleveland, Ohio, United States
• Cleveland Clinic Main Campus /ID# 231135 — Cleveland, Ohio, United States
• Penn State Hershey Medical Ctr /ID# 229837 — Hershey, Pennsylvania, United States
• Monash Medical Centre /ID# 231379 — Clayton, Victoria, Australia
• Austin Health /ID# 231378 — Heidelberg, Victoria, Australia
• Rambam Health Care Campus /ID# 229555 — Haifa, H_efa, Israel
• The Chaim Sheba Medical Center /ID# 226812 — Ramat Gan, Tel Aviv, Israel
• Pan American Center for Oncology Trials, LLC /ID# 228210 — Rio Piedras, Puerto Rico
• Yonsei University Health System Severance Hospital /ID# 230280 — Seoul, Seoul Teugbyeolsi, South Korea
• Asan Medical Center /ID# 230282 — Seoul, Seoul Teugbyeolsi, South Korea
• Hospital Universitario Vall d'Hebron /ID# 230226 — Barcelona, Spain
• Hospital Universitario 12 de Octubre /ID# 230102 — Madrid, Spain
• Hospital Universitario Miguel Servet /ID# 230139 — Zaragoza, Spain

Full record on ClinicalTrials.gov

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