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

NCT ID: NCT04807972

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-28
• Study Completion Date: 2024-03-25

Brief Summary

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.

Detailed Description

Study study was terminated before the Phase 2 portion of the study began.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1b Dose Escalation

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

Group Type: EXPERIMENTAL

ABBV-927

Intervention Type: DRUG

Intravenous (IV) Infusion

Budiglimab

Intervention Type: DRUG

Intravenous (IV) Infusion

modified FOLFIRINOX

Intervention Type: DRUG

Intravenous (IV) Infusion

Interventions

ABBV-927

Intravenous (IV) Infusion

Intervention Type: DRUG

Budiglimab

Intravenous (IV) Infusion

Intervention Type: DRUG

modified FOLFIRINOX

Intravenous (IV) Infusion

Intervention Type: DRUG

Other Intervention Names

ABBV-181; mFFX

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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

Countries

United States; Australia; Israel; Puerto Rico; South Korea; Spain

Other Identifiers

2020-005767-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M20-732

Identifier Type: -

Identifier Source: org_study_id