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Monoclonal Antibodies

ABBV-927 + Budigalimab + mFOLFIRINOX for Pancreatic Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Body weight >= 35 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months.
Awards & highlights

Study Summary

This trial will help researchers learn if the investigational drugs are safe and effective for treating Metastatic Pancreatic Cancer Disease.

Who is the study for?
Adults aged 18-75 with a body weight of at least 35 kg and diagnosed with metastatic pancreatic cancer can join. They must have measurable disease activity but no recent treatments, CNS metastases, or significant fluid accumulation in the body.Check my eligibility
What is being tested?
The trial is testing ABBV-927 and Budigalimab (investigational drugs) combined with modified FOLFIRINOX chemotherapy for treating metastatic pancreatic cancer. Participants will be divided into groups receiving different combinations of these drugs.See study design
What are the potential side effects?
Potential side effects include reactions to IV infusions, increased risk of infections due to immune system effects, nausea from chemotherapy, fatigue, and possibly other organ-related inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have another cancer type but it's under control and doesn't need treatment.
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My body weight is at least 35 kg.
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My body weight is at least 35 kg.
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My cancer is a type of pancreatic cancer that has spread to other parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1b: Number of Participants with Dose Limiting Toxicities (DLT)
Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Laboratory (Hematological and Chemistry) Values
Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Vital Signs
+2 more
Secondary outcome measures
Phase 1b and Phase 2: Area Under the Concentration-time Curve Over the Time Interval (AUC) in Plasma
Phase 1b and Phase 2: Clinical Benefit Rate (CBR)
Phase 1b and Phase 2: Duration of Response (DOR) for Participants Who Achieve a Documented Confirmed Response of CR/PR
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2 Cohort C ExpansionExperimental Treatment3 Interventions
Participants will receive modified FOLFIRINOX (Day 1 and Day 15) + ABBV 927 and Budigalimab as Intravenous (IV) Infusion in each 28 day cycle.
Group II: Phase 2 Cohort BExperimental Treatment2 Interventions
Participants will receive modified FOLFIRINOX (Day 1 and Day 15) + ABBV-927 in each 28 day cycle.
Group III: Phase 2 Cohort AExperimental Treatment1 Intervention
Participants will receive modified FOLFIRINOX on Day 1 and Day 15 of each 28 day cycle.
Group IV: Phase 1b Dose EscalationExperimental Treatment3 Interventions
Participants will receive escalating doses of ABBV-927 in combination with modified FOLFIRINOX (mFFX) and Budigalimab.

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
947 Previous Clinical Trials
496,552 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
388 Previous Clinical Trials
141,233 Total Patients Enrolled

Media Library

ABBV-927 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04807972 — Phase 1 & 2
Pancreatic Cancer Research Study Groups: Phase 2 Cohort B, Phase 2 Cohort C Expansion, Phase 1b Dose Escalation, Phase 2 Cohort A
ABBV-927 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04807972 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it currently possible to sign-up for this experiment?

"That is correct. The listing on clinicaltrials.gov reveals that the research team is actively recruiting patients for this trial. 129 subjects are needed in total, with 10 different hospitals participating."

Answered by AI

What is the current FDA stance on modified FOLFIRINOX?

"There is some clinical data suggesting that modified FOLFIRINOX is safe, but none yet attesting to its efficacy. Consequently, it received a score of 2."

Answered by AI

By what means does this research plan to achieve its objectives?

"The primary outcome that will be measured over a 6-month period is overall survival. Additionally, this trial will also assess secondary outcomes including time to maximum observed plasma concentration (Tmax), objective response rate (ORR), and clinical benefit rate (CBR)."

Answered by AI

Could elderly patients over the age of 60 still be eligible for this clinical trial?

"As this study requires, participants must be between 18-75 years old."

Answered by AI

How many hospitals are running this trial?

"To limit participant inconvenience, the 10 enrolling centres for this study are localised. If you wish to take part in this research, please choose the clinic nearest to your residence from Cleveland, Springdale, Kettering or the other 10 locations."

Answered by AI

Are there any other investigations that have looked at modified FOLFIRINOX?

"There are 210 clinical trial sites for modified FOLFIRINOX with seven of them being active. Most of the research for this procedure is based in Hamburg and Lazio."

Answered by AI

How many individuals are currently involved in this clinical trial?

"That is correct, the trial is still actively looking for patients. According to the listing on clinicaltrials.gov, the original posting was on May 28th, 2021 and there have been edits as recently as May 23rd, 2022. They are hoping to find 129 people total from 10 different locations."

Answered by AI

What is the unique aspect of this clinical trial?

"Since 2018, modified FOLFIRINOX has been the subject of clinical research studies. The very first one was sponsored by AbbVie and took place in that same year. This initial study had 233 participants. Based on the success of this Phase 1 trial, the drug was approved for public use. As of now, there are 7 ongoing trials involving modified FOLFIRINOX being conducted in 13 different countries and 99 cities total."

Answered by AI

If I wanted to, how could I sign up for this clinical research?

"129 patients are being recruited for this clinical trial that requires participants to have cancer of the pancreas and be between 18-75 years old."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
How old are they?
18 - 65
What site did they apply to?
UCHSC Anschultz Cancer Pavilion /ID# 227841
What portion of applicants met pre-screening criteria?
Met criteria
~10 spots leftby Mar 2025