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Locally Advanced Unresectable or Metastatic Gastric AdenocarcinomaPhase 2AndroMETa-GEANCT06628310

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

A Phase 2 study testing Telisotuzumab Adizutecan, Budigalimab and Fluorouracil in people with Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by AbbVie at 49 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Telisotuzumab Adizutecan, Budigalimab and Fluorouracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
185 participants
Where
49 sitesin 11 countries
Study dates
13 Dec 2024to Oct 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

49 sites in 11 countries.

49 sites in 11 countries

United States8 sites

  • City of Hope National Medical Center /ID# 268690

    Duarte, California, 91010

  • Duke University Medical Center /ID# 268186

    Durham, North Carolina, 27710

  • Hattiesburg Clinic /ID# 268572

    Hattiesburg, Mississippi, 39401

  • Millennium Physicians /ID# 268540

    Houston, Texas, 77090

  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 272630

    Irvine, California, 92618

  • City Of Hope - Atlanta /ID# 280646

    Newnan, Georgia, 30265

  • AdventHealth Orlando /ID# 268561

    Orlando, Florida, 32803

  • UCLA - Santa Monica /ID# 270024

    Santa Monica, California, 90404

Other trials in United States

Taiwan6 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 267672

    Kaohsiung City, 807

  • China Medical University Hospital /ID# 267667

    Taichung, 40447

  • National Cheng Kung University Hospital /ID# 267669

    Tainan, 704

  • National Taiwan University Hospital /ID# 267666

    Taipei, 100

  • Taipei Veterans General Hospital /ID# 267664

    Taipei, 112

  • Linkou Chang Gung Memorial Hospital /ID# 267668

    Taoyuan City, 333

Other trials in Taiwan

China5 sites

  • Beijing Cancer Hospital /ID# 268455

    Beijing, Beijing Municipality, 100142

  • The first Affiliated Hospital, Zhejiang University School of Medicine. /ID# 268782

    Hangzhou, Zhejiang, 310003

  • Harbin Medical University Cancer Hospital /ID# 268452

    Harbin, Heilongjiang, 150081

  • Cancer Hospital Chinese Academy of Medical Sciences(Langfang) /ID# 277479

    Langfang, Hebei, 065000

  • Union Hospital - Tongji Medical College /ID# 268796

    Wuhan, Hubei, 430022

Other trials in China

Germany5 sites

  • Krankenhaus Nordwest /ID# 268462

    Frankfurt am Main, Hesse, 60488

  • Universitaetsklinikum Freiburg /ID# 270407

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Haematologisch-Onkologische Praxis Eppendorf /ID# 268024

    Hamburg, 20249

  • Universitaetsklinikum Leipzig /ID# 270432

    Leipzig, Saxony, 04103

  • TUM Klinikum rechts der Isar /ID# 267792

    Munich, Bavaria, 81675

Other trials in Germany

Israel5 sites

  • Soroka Medical Center /ID# 268301

    Beersheba, Southern District, 8410101

  • Shaare Zedek Medical Center /ID# 267752

    Jerusalem, 9103102

  • Hadassah Medical Center-Hebrew University /ID# 267753

    Jerusalem, 91120

  • Meir Medical Center /ID# 267998

    Kefar Sava, Central District, 4428164

  • Tel Aviv Sourasky Medical Center /ID# 267755

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Japan5 sites

  • National Cancer Center Hospital /ID# 268648

    Chuo-Ku, Tokyo, 104-0045

  • National Cancer Center Hospital East /ID# 268083

    Kashiwa-shi, Chiba, 277-8577

  • The Cancer Institute Hospital Of JFCR /ID# 268656

    Koto-ku, Tokyo, 135-8550

  • Aichi Cancer Center /ID# 268124

    Nagoya, Aichi-ken, 464-8681

  • Shizuoka Cancer Center /ID# 268123

    Sunto-gun, Shizuoka, 411-8777

Other trials in Japan

Spain4 sites

  • Hospital General Universitario Gregorio Maranon /ID# 270037

    Madrid, 28007

  • Complexo Hospitalario Universitario de Ourense /ID# 270042

    Ourense, 32005

  • Hospital Universitario de Navarra /ID# 270119

    Pamplona, Navarre, 31008

  • Hospital Clinico Universitario de Valencia /ID# 270040

    Valencia, 46010

Other trials in Spain

United Kingdom4 sites

  • Queen Elizabeth Hospital Birmingham /ID# 271199

    Birmingham, B15 2TH

  • NHS Tayside Health Board /ID# 270799

    Dundee, DD2 1SG

  • Barts Health NHS Trust /ID# 270796

    London, Greater London, E1 2ES

  • Oxford University Hospital NHS Trust /ID# 274614

    Oxford, Oxfordshire, OX3 7LE

Other trials in United Kingdom

Belgium3 sites

  • Algemeen Ziekenhuis klina /ID# 268754

    Brasschaat, Antwerpen, 2930

  • Universitair Ziekenhuis Leuven /ID# 269957

    Leuven, Vlaams-Brabant, 3000

  • CHU de Liege /ID# 270223

    Liège, 4000

Other trials in Belgium

Canada3 sites

  • Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 268763

    Montreal, Quebec, H2X 0C1

  • Jewish General Hospital /ID# 268413

    Montreal, Quebec, H3T 1E2

  • Princess Margaret Cancer Centre /ID# 268277

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Puerto Rico1 site

  • Pan American Center for Oncology Trials - Rio Piedras /ID# 268833

    Rio Piedras, 00935

Other trials in Puerto Rico

About this study

Official title: 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.

Read more

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.

Being tested
Telisotuzumab Adizutecan, Budigalimab, Fluorouracil, Leucovorin, Oxaliplatin
Keywords
Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma, ABBV-400, ABBV-181, Budigalimab, Telisotuzumab Adizutecan
Medical subject headings
Adenocarcinoma Of Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telisotuzumab AdizutecanDrug

    Also called ABBV-400

    Intravenous (IV) Infusion

  • BudigalimabDrug

    Also called ABBV-181

    IV Infusion

  • FluorouracilDrug

    IV Infusion; IV Injection

  • LeucovorinDrug

    Also called Folinic Acid

    IV Infusion; IV Injection

  • OxaliplatinDrug

    IV Infusion

Study groups in NCT06628310
Study groupRoleWhat they receive
Stage 1: Dose Escalation ABBV-400ExperimentalParticipants 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.
Receives: Drug: Telisotuzumab Adizutecan; Drug: Budigalimab; Drug: Fluorouracil; Drug: Leucovorin
Stage 2 Arm 1: Dose Optimization ABBV-400 Dose AExperimentalParticipants 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.
Receives: Drug: Telisotuzumab Adizutecan; Drug: Budigalimab; Drug: Fluorouracil; Drug: Leucovorin
Stage 2 Arm 2: Dose Optimization ABBV-400 Dose BExperimentalParticipants 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.
Receives: Drug: Telisotuzumab Adizutecan; Drug: Budigalimab; Drug: Fluorouracil; Drug: Leucovorin
Stage 2 Arm 3: Dose Optimization Standard of Care (SOC)ExperimentalParticipants will receive a fixed dose of leucovorin (folinic acid), fluorouracil, oxaliplatin (FOLFOX) and budigalimab as part of the approximately 6 year study duration.
Receives: Drug: Budigalimab; Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) as Assessed by Investigator

    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.

    Measured: Through Study Completion, Approximately 6 Years

  2. Percentage of Participants with Objective Response (OR) as Assessed by Investigator

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

    Measured: Through Study Completion, Approximately 6 Years

Secondary outcomes (3)

  1. Percentage of Participants Achieving Disease Control (DC) as Assessed by Investigator

    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.

    Measured: Through Study Completion, Approximately 6 Years

  2. Duration of Response (DOR) as Assessed by Investigator

    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.

    Measured: Through Study Completion, Approximately 6 Years

  3. Overall Survival (OS)

    OS is defined as the time from first dose of study drug to the event of death from any cause.

    Measured: Through Study Completion, Approximately 6 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2024
  2. Study start13 Dec 2024
  3. Primary completionOct 2030 (estimated)
  4. Study completionOct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06628310
Sponsor's protocol ID
M24-977
Other IDs
2024-513008-32, 2024-513008-32-00
Acronym
AndroMETa-GEA
Status last verified
Jul 2026
First submitted
3 Oct 2024
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telisotuzumab Adizutecan, Budigalimab and Fluorouracil in people with Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by AbbVie at 49 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Taiwan, China, Germany, Israel and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) as Assessed by Investigator (time frame: Through Study Completion, Approximately 6 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06628310.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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