A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) ABBV-400 in Combination With IV Fluorouracil, Leucovorin, and Budigalimab in Adult Participants With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
Active, not recruiting · Phase 2 · NCT06628310
Conditions: Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
At a glance
- Research payments reported, 2025
- $310,954
- U.S. investigators named
- 7
- Sites paid
- 7
- Planned or actual enrollment
- 185
About the trial
- Sponsor
- AbbVie
- Tested
- Telisotuzumab Adizutecan (drug), Budigalimab (drug), Fluorouracil (drug), Leucovorin (drug), Oxaliplatin (drug)
- Dates
- Started 2024-12-13; completion 2030-10
- Results posted
- Not yet
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan (ABBV-400) is given in combination with Fluorouracil, Leucovorin, and a programmed cell death receptor 1 (PD1) inhibitor Budigalimab. The combination (AFLB) will be given to adult participants to treat locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEA). Telisotuzumab Adizutecan (ABBV-400) and Budigalimab are investigational drugs being developed for the treatment of mGEA. Fluorouracil and Leucovorin are drugs approved…
From ClinicalTrials.gov, last updated 2026-07-21. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $310,954 in research payments for this study in 2025 (27 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Dani R. Castillo, MD Medical Oncology · Duarte, CA
- Zev A. Wainberg, MD Hematology & Oncology · Santa Monica, CA
- Mohamedtaki A. Tejani, M.D. Medical Oncology · Orlando, FL
- John S. Hrom, MD Hematology & Oncology · Hattiesburg, MS
- Hope E. Uronis, MD Internal Medicine · Durham, NC
- Marcia R. Cruz-correa, MD Gastroenterology · Rio Piedras, PR
- Murtaza N. Bhuriwala, MD Medical Oncology · Tomball, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- City of Hope National Medical Ctr $111,704
- Hattiesburg Clinic PA $99,060
- Resnick Neuropsychiatric Hospital at UCLA, CA $56,644
- Millenium Research & Clincal $29,504
- Adventhealth Orlando, FL $5,779
- Pan American Center for Oncology $5,263
- Duke University $3,000
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.