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
← catalyst calendarNCT06628310 · readout ≤ 1,534 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
185actual
Sites
49
Countries
Belgium, Canada, China +8
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-12-13 | actual | When the study began enrolling |
| Primary completion | Oct 2030 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Oct 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2024-10-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-21 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma
- Gastroesophageal Junction Adenocarcinoma
- Esophageal Adenocarcinoma
Interventions
- Drug: Telisotuzumab Adizutecan — also filed as ABBV-400
- Drug: Budigalimab — also filed as ABBV-181
- Drug: Fluorouracil
- Drug: Leucovorin — also filed as Folinic Acid
- Drug: Oxaliplatin
Primary outcomes
what the primary-completion date above is the date OFProgression-Free Survival (PFS) as Assessed by Investigator
measured Through Study Completion, Approximately 6 Years
Percentage of Participants with Objective Response (OR) as Assessed by Investigator
measured Through Study Completion, Approximately 6 Years
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