Trial purpose
Cancer treatment
Tumor type
Upper gastrointestinal tract
Age
18 - 75
Clinical summary
Summary
This randomised, open-label trial has two phases. In the first phase (dose escalation), participants will receive escalating doses of ABBV-927 (administered intravenously [IV]), in combination with modified FOLFIRINOX (mFFX) (IV) and budigalimab (IV). The second phase has three cohorts. In Phase 2 Cohort A, participants will receive mFFX (via IV) monotherapy, on Day 1 and Day 15 of each 28 day cycle. In Phase 2 Cohort B, participants will receive mFFX (via IV) on Day 1 and Day 15, in combination with ABBV-927 (via IV) in each 28 day cycle. In Phase 2 Cohort C Expansion, participants will receive mFFX (via IV) on Day 1 and Day 15, in combination with ABBV-927 (via IV) and budigalimab (via IV) in each 28 day cycle.
Conditions
This trial is treating people with pancreatic cancer
Eligibility
Inclusion
- 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
- 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).
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
AbbVie
Scientific Title
A Phase 1b/2, Randomized, Controlled, Open-Label 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
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