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
Headshot of Hope Elizabeth Uronis
Associate Professor of Medicine
Protocol Number
IRB: PRO00116375
NCT: NCT06628310
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF
More Information