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

NCT04807972 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: M20-7322020-005767-31
• Study Type: interventional
• Target: 40
• Locations: 6 countries
• Sites: 15

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.

Conditions

Pancreatic Cancer

Keywords

Metastatic Pancreatic Cancer Disease; ABBV-927; Modified Folfirinox (mFFX); Budigalimab; ABBV-181; Cancer

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Up to 6 months

Secondary Outcomes (8)

• Phase 1b: Maximum Plasma Concentration (Cmax)

  Up to approximately 3 months

• Phase 1b: Time to Maximum Observed Plasma Concentration (Tmax)

  Up to approximately 3 months

• Phase 1b: Area Under the Concentration-time Curve Over the Time Interval (AUC) in Plasma

  Up to approximately 3 months.

• Phase 1b: Objective Response Rate (ORR)

  Up to approximately 27 months

• Phase 1b: Clinical Benefit Rate (CBR)

  Up to approximately 27 months

Study Arms (1)

Phase 1b Dose Escalation

EXPERIMENTAL

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

Drug: ABBV-927; Drug: Budiglimab; Drug: modified FOLFIRINOX

Interventions

ABBV-927 DRUG

Intravenous (IV) Infusion

Phase 1b Dose Escalation

Budiglimab DRUG

Intravenous (IV) Infusion

Also known as: ABBV-181

Phase 1b Dose Escalation

modified FOLFIRINOX DRUG

Intravenous (IV) Infusion

Also known as: mFFX

Phase 1b Dose Escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• AbbVie: lead

Study Sites (15)

UCHSC Anschultz Cancer Pavilion /ID# 227841

Aurora, Colorado, 80045-2517, United States

Location

Johns Hopkins Hospital /ID# 226713

Baltimore, Maryland, 21287, United States

Location

Univ Hosp Cleveland /ID# 226807

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Main Campus /ID# 231135

Cleveland, Ohio, 44195, United States

Location

Penn State Hershey Medical Ctr /ID# 229837

Hershey, Pennsylvania, 17033-2360, United States

Location

Monash Medical Centre /ID# 231379

Clayton, Victoria, 3168, Australia

Location

Austin Health /ID# 231378

Heidelberg, Victoria, 3084, Australia

Location

Rambam Health Care Campus /ID# 229555

Haifa, H_efa, 3109601, Israel

Location

The Chaim Sheba Medical Center /ID# 226812

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Pan American Center for Oncology Trials, LLC /ID# 228210

Rio Piedras, 00935, Puerto Rico

Location

Yonsei University Health System Severance Hospital /ID# 230280

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Asan Medical Center /ID# 230282

Seoul, Seoul Teugbyeolsi, 05505, South Korea

Location

Hospital Universitario Vall d'Hebron /ID# 230226

Barcelona, 08035, Spain

Location

Hospital Universitario 12 de Octubre /ID# 230102

Madrid, 28041, Spain

Location

Hospital Universitario Miguel Servet /ID# 230139

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Interventions

budigalimab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 19, 2021
• Study Start: May 28, 2021
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (5); ES (3); IL (2); AU (2); PR (1); KR (2)