ABBV-400 + 5-FU, leucovorin, and budigalimab for gastroesophageal adenocarcinoma
What is the Purpose of this Study?
We are doing this study to see if the study drugs ABBV-400 and budigalimab, in combination with chemotherapy, are a safe and effective option for treating gastroesophageal cancer. We are also trying to find the best dose of ABBV-400 to use.
What is the Condition Being Studied?
Gastroesophageal Adenocarcinoma
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with gastroesophageal adenocarcinoma
- Have disease that is inoperable, advanced, or metastatic
- Have not received any previous treatment for their cancer
For more information, contact the study team at dana.a.warren@duke.edu.
Age Group
Adults
What is Involved?
If you choose to join this study, you will:
- Receive infusions of budigalimab every 4 weeks
- Receive chemotherapy every 2 weeks
- Have your tumor biopsied
- Give blood samples
- Have regular CT or MRI scans
Depending on which arm of the study you are assigned to join, you may:
- Receive infusions of ABBV-400 every 2 weeks; OR
- Receive infusions of ABBV-400 every 4 weeks: OR
- Receive no doses of ABBV-400
Study Details
Full Title
[M24-977] A Phase 2 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination with Fluorouracil, Leucovorin, and Budigalimab as First-Line Treatment in Patients with Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (AndroMETa-GEA-977)
Principal Investigator
Associate Professor of Medicine
Protocol Number
IRB:
PRO00116375
NCT:
NCT06628310
Phase
Phase
II
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF
More Information
Call 919-668-1861
or email gi-oncology-cru@dm.duke.edu