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.
Who Can Participate?
Eligibility
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
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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
- Receive infusions of ABBV-400 every 2 weeks; OR
- Receive infusions of ABBV-400 every 4 weeks: OR
- Receive no doses of ABBV-400
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
Hope
Uronis
Protocol Number
PRO00116375
NCT ID
NCT06628310
Phase
II
Enrollment Status
Pending Open to Enrollment