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

Phase 1

• Conditions: ntreated Metastatic Pancreatic Adenocarcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-005767-31-ES
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-23
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

1) Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with metastatic disease
2) Measurable disease per RECIST 1.1
3) ECOG 0 or 1 and life expectancy of > 3 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 97
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

1) Previous radiotherapy, surgery, or systemic anti-cancer therapy for the treatment of metastatic pancreatic adenocarcinoma
2) Clinically significant third-space fluid accumulation
3) History of inflammatory bowel disease, non-infectious pneumonitis, interstitial lung disease, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS)
4) Positive test results for HIV, or subjects with chronic or active hepatitis B or C
5) Clinically significant uncontrolled medical conditions

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified