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NCT06628310

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
PHASE2Ages 18+InterventionalTreatment
AbbVie
~185 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Telisotuzumab AdizutecanBudigalimabFluorouracilLeucovorinOxaliplatin

At a glance

Recruiting sites
0 of 49 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS) as Assessed by Investigator
Measured over Through Study Completion, Approximately 6 Years
+1 more outcome measured

Conditions

Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Esophageal Adenocarcinoma

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Where it's being run

49 sites across 36 states
Taiwan6
California3
Spain3
Quebec2
Israel2
Tokyo2
United Kingdom2
Florida1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Have inoperable, advanced or metastatic histologically- or cytologically confirmed gastric, gastroesophageal junction, or esophageal adenocarcinoma.
Have measurable disease determined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Human epidermal growth factor receptor 2 (HER2) negative disease, defined as immunohistochemistry (IHC) (0, or 1+) or fluorescence in situ hybridization (FISH) negative.
Known programmed death ligand 1 (PD-L1) status at screening, or availability of tumor tissue for central PD-L1 testing prior to enrollment.

Exclusion

Have prior systemic therapy in the locally advanced, unresectable, or metastatic setting.
History of clinically significant, intercurrent lung-specific illnesses including, but not limited to those listed in the protocol.

What this trial measures

  • Progression-Free Survival (PFS) as Assessed by InvestigatorThrough Study Completion, Approximately 6 Years

    PFS is defined as the time from the first dose of study drug to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by investigator or death from any cause, whichever occurs earlier.

  • Percentage of Participants with Objective Response (OR) as Assessed by InvestigatorThrough Study Completion, Approximately 6 Years

    OR is defined as confirmed complete response (CR) or confirmed partial response (PR) as assessed by investigator per RECIST version 1.1.