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 (AndroMETa-GEA)

March 26, 2026 updated by: AbbVie

A Phase 2 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Fluorouracil, Leucovorin, and Budigalimab as First-Line Treatment in Subjects With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (AndroMETa-GEA-977)

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 for the treatment of mGEA. This study will be divided into two stages, with the first stage treating participants with increasing doses of ABBV-400 within the AFLB regimen until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into groups called treatment arms where one group will receive Budigalimab and FOLFOX (Fluorouracil, Leucovorin, and Oxaliplatin) . A further two treatment groups will receive AFLB, but with two optimized doses of ABBV-400 to allow for the best dose to be studied in the future. Approximately 180 adult participants with mGEA will be enrolled in the study in 51 sites worldwide.

In the dose escalation stage, participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan (ABBV-400) within the AFLB regimen until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage, participants will receive FOLFOX or receive AFLB, but with one of two optimized doses of ABBV-400. The study will run for a duration of approximately 6 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • Recruiting
        • CHU de Liege /ID# 270223
    • Antwerpen
      • Brasschaat, Antwerpen, Belgium, 2930
        • Recruiting
        • Algemeen Ziekenhuis klina /ID# 268754
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • Universitair Ziekenhuis Leuven /ID# 269957
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre /ID# 268277
    • Quebec
      • Montreal, Quebec, Canada, H2X 0C1
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 268763
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital /ID# 268413
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer Hospital /ID# 268455
    • Hebei
      • Langfang, Hebei, China, 065000
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences(Langfang) /ID# 277479
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital /ID# 268452
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital - Tongji Medical College /ID# 268796
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The first Affiliated Hospital, Zhejiang University School of Medicine. /ID# 268782
  • Germany
      • Hamburg, Germany, 20249
        • Recruiting
        • Haematologisch-Onkologische Praxis Eppendorf /ID# 268024
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • Recruiting
        • Universitaetsklinikum Freiburg /ID# 270407
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Recruiting
        • TUM Klinikum rechts der Isar /ID# 267792
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60488
        • Recruiting
        • Krankenhaus Nordwest /ID# 268462
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • Universitaetsklinikum Leipzig /ID# 270432
  • Israel
      • Jerusalem, Israel, 91120
        • Recruiting
        • Hadassah Medical Center-Hebrew University /ID# 267753
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center /ID# 267752
    • Central District
      • Kfar Saba, Central District, Israel, 4428164
        • Recruiting
        • Meir Medical Center /ID# 267998
    • Southern District
      • Beersheba, Southern District, Israel, 8410101
        • Recruiting
        • Soroka Medical Center /ID# 268301
    • Tel Aviv
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center /ID# 267755
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center /ID# 268124
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East /ID# 268083
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Recruiting
        • Shizuoka Cancer Center /ID# 268123
    • Tokyo
      • Chuo-Ku, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital /ID# 268648
      • Koto-ku, Tokyo, Japan, 135-8550
        • Recruiting
        • The Cancer Institute Hospital Of JFCR /ID# 268656
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Recruiting
        • Pan American Center for Oncology Trials /ID# 268833
  • Spain
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Maranon /ID# 270037
      • Ourense, Spain, 32005
        • Recruiting
        • Complexo Hospitalario Universitario de Ourense /ID# 270042
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia /ID# 270040
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Hospital Universitario de Navarra /ID# 270119
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 267672
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital /ID# 267667
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital /ID# 267669
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital /ID# 267664
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital /ID# 267666
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Linkou Chang Gung Memorial Hospital /ID# 267668
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • Queen Elizabeth Hospital Birmingham /ID# 271199
      • Dundee, United Kingdom, DD2 1SG
        • Recruiting
        • NHS Tayside Health Board /ID# 270799
    • Greater London
      • London, Greater London, United Kingdom, E1 2ES
        • Recruiting
        • Barts Health NHS Trust /ID# 270796
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Recruiting
        • Oxford University Hospital NHS Trust /ID# 274614
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Medical Center /ID# 268690
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 272630
      • Santa Monica, California, United States, 90404
        • Recruiting
        • UCLA - Santa Monica /ID# 270024
    • Florida
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando /ID# 268561
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Recruiting
        • City Of Hope - Atlanta. /ID# 280646
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Recruiting
        • Hattiesburg Clinic /ID# 268572
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center /ID# 268186
    • Texas
      • Houston, Texas, United States, 77090
        • Recruiting
        • Millennium Research & Clinical Development /ID# 268540

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stage 2 Arm 3: Dose Optimization Standard of Care (SOC)
Participants will receive a fixed dose of leucovorin (folinic acid), fluorouracil, oxaliplatin (FOLFOX) and budigalimab as part of the approximately 6 year study duration.
Drug: Budigalimab
IV Infusion
Other Names:
  • ABBV-181
Drug: Oxaliplatin
IV Infusion
Drug: Fluorouracil
IV Infusion; IV Injection
Drug: Leucovorin
IV Infusion; IV Injection
Other Names:
  • Folinic Acid
Experimental: Stage 1: Dose Escalation ABBV-400
Participants will receive escalating doses of telisotuzumab adizutecan (ABBV-400) in combination with a fixed dose of fluorouracil, leucovorin and budigalimab as part of the approximately 6 year study duration.
Drug: Budigalimab
IV Infusion
Other Names:
  • ABBV-181
Drug: Fluorouracil
IV Infusion; IV Injection
Drug: Leucovorin
IV Infusion; IV Injection
Other Names:
  • Folinic Acid
Drug: Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Other Names:
  • ABBV-400
Experimental: Stage 2 Arm 1: Dose Optimization ABBV-400 Dose A
Participants will receive telisotuzumab adizutecan (ABBV-400) dose A in combination with a fixed dose of fluorouracil, leucovorin and budigalimab as part of the approximately 6 year study duration.
Drug: Budigalimab
IV Infusion
Other Names:
  • ABBV-181
Drug: Fluorouracil
IV Infusion; IV Injection
Drug: Leucovorin
IV Infusion; IV Injection
Other Names:
  • Folinic Acid
Drug: Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Other Names:
  • ABBV-400
Experimental: Stage 2 Arm 2: Dose Optimization ABBV-400 Dose B
Participants will receive telisotuzumab adizutecan (ABBV-400) dose B in combination with a fixed dose of fluorouracil, leucovorin and budigalimab as part of the approximately 6 year study duration.
Drug: Budigalimab
IV Infusion
Other Names:
  • ABBV-181
Drug: Fluorouracil
IV Infusion; IV Injection
Drug: Leucovorin
IV Infusion; IV Injection
Other Names:
  • Folinic Acid
Drug: Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Other Names:
  • ABBV-400

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) as Assessed by Investigator
Time Frame: Through 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.
Through Study Completion, Approximately 6 Years
Percentage of Participants with Objective Response (OR) as Assessed by Investigator
Time Frame: Through 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.
Through Study Completion, Approximately 6 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR) as Assessed by Investigator
Time Frame: Through Study Completion, Approximately 6 Years
DOR is defined as the time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST version 1.1 as determined by investigator or death from any cause, whichever occurs first.
Through Study Completion, Approximately 6 Years
Overall Survival (OS)
Time Frame: Through Study Completion, Approximately 6 Years
OS is defined as the time from first dose of study drug to the event of death from any cause.
Through Study Completion, Approximately 6 Years
Percentage of Participants Achieving Disease Control (DC) as Assessed by Investigator
Time Frame: Through Study Completion, Approximately 6 Years
DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) (with a minimum duration of 14 weeks) based on RECIST, version 1.1 as determined by the investigator.
Through Study Completion, Approximately 6 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2024

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

October 1, 2030

Study Registration Dates

First Submitted

October 3, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M24-977
  • 2024-513008-32 (Other Identifier: EU CT)
  • 2024-513008-32-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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