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New drug cocktail aims to shrink stomach tumors in Mid-Stage trial

NCT ID NCT06628310

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This Phase 2 study tests a new drug, telisotuzumab adizutecan (ABBV-400), combined with standard chemotherapy and an immunotherapy drug for people with advanced stomach, gastroesophageal junction, or esophageal cancer that cannot be removed by surgery. About 180 adults will receive either the new combo or standard treatment to see which works better at slowing cancer growth. The study will also find the best dose of the new drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Telisotuzumab adizutecan (ABBV-400) combined with budigalimab, fluorouracil, and leucovorin
What this could lead to
If successful, this could offer a new first-line treatment option for people with advanced stomach or esophageal cancer, potentially improving how long they live without their cancer growing.
What could go wrong
This is an early Phase 2 trial with only 180 participants, so results may not apply to everyone. The new drug combination may cause side effects or not work better than current treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

185 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma Of Esophagus esophageal adenocarcinoma gastric adenocarcinoma gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal adenocarcinoma Gastroesophageal junction adenocarcinoma Locally advanced unresectable or metastatic gastric adenocarcinoma

Contacts and locations

Locations

  • AdventHealth Orlando /ID# 268561

    Orlando, Florida, 32803, United States

  • Aichi Cancer Center /ID# 268124

    Nagoya, Aichi-ken, 464-8681, Japan

  • Algemeen Ziekenhuis klina /ID# 268754

    Brasschaat, Antwerpen, 2930, Belgium

  • Barts Health NHS Trust /ID# 270796

    London, Greater London, E1 2ES, United Kingdom

  • Beijing Cancer Hospital /ID# 268455

    Beijing, Beijing Municipality, 100142, China

  • CHU de Liege /ID# 270223

    Liège, 4000, Belgium

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

    Langfang, Hebei, 065000, China

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

    Montreal, Quebec, H2X 0C1, Canada

  • China Medical University Hospital /ID# 267667

    Taichung, 40447, Taiwan

  • City Of Hope - Atlanta /ID# 280646

    Newnan, Georgia, 30265, United States

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

    Irvine, California, 92618, United States

  • City of Hope National Medical Center /ID# 268690

    Duarte, California, 91010, United States

  • Complexo Hospitalario Universitario de Ourense /ID# 270042

    Ourense, 32005, Spain

  • Duke University Medical Center /ID# 268186

    Durham, North Carolina, 27710, United States

  • Hadassah Medical Center-Hebrew University /ID# 267753

    Jerusalem, 91120, Israel

  • Haematologisch-Onkologische Praxis Eppendorf /ID# 268024

    Hamburg, 20249, Germany

  • Harbin Medical University Cancer Hospital /ID# 268452

    Harbin, Heilongjiang, 150081, China

  • Hattiesburg Clinic /ID# 268572

    Hattiesburg, Mississippi, 39401, United States

  • Hospital Clinico Universitario de Valencia /ID# 270040

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Maranon /ID# 270037

    Madrid, 28007, Spain

  • Hospital Universitario de Navarra /ID# 270119

    Pamplona, Navarre, 31008, Spain

  • Jewish General Hospital /ID# 268413

    Montreal, Quebec, H3T 1E2, Canada

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

    Kaohsiung City, 807, Taiwan

  • Krankenhaus Nordwest /ID# 268462

    Frankfurt am Main, Hesse, 60488, Germany

  • Linkou Chang Gung Memorial Hospital /ID# 267668

    Taoyuan City, 333, Taiwan

  • Meir Medical Center /ID# 267998

    Kefar Sava, Central District, 4428164, Israel

  • Millennium Physicians /ID# 268540

    Houston, Texas, 77090, United States

  • NHS Tayside Health Board /ID# 270799

    Dundee, DD2 1SG, United Kingdom

  • National Cancer Center Hospital /ID# 268648

    Chuo-Ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East /ID# 268083

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital /ID# 267669

    Tainan, 704, Taiwan

  • National Taiwan University Hospital /ID# 267666

    Taipei, 100, Taiwan

  • Oxford University Hospital NHS Trust /ID# 274614

    Oxford, Oxfordshire, OX3 7LE, United Kingdom

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

    Rio Piedras, 00935, Puerto Rico

  • Princess Margaret Cancer Centre /ID# 268277

    Toronto, Ontario, M5G 2M9, Canada

  • Queen Elizabeth Hospital Birmingham /ID# 271199

    Birmingham, B15 2TH, United Kingdom

  • Shaare Zedek Medical Center /ID# 267752

    Jerusalem, 9103102, Israel

  • Shizuoka Cancer Center /ID# 268123

    Sunto-gun, Shizuoka, 411-8777, Japan

  • Soroka Medical Center /ID# 268301

    Beersheba, Southern District, 8410101, Israel

  • TUM Klinikum rechts der Isar /ID# 267792

    Munich, Bavaria, 81675, Germany

  • Taipei Veterans General Hospital /ID# 267664

    Taipei, 112, Taiwan

  • Tel Aviv Sourasky Medical Center /ID# 267755

    Tel Aviv, Tel Aviv, 6423906, Israel

  • The Cancer Institute Hospital Of JFCR /ID# 268656

    Koto-ku, Tokyo, 135-8550, Japan

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

    Hangzhou, Zhejiang, 310003, China

  • UCLA - Santa Monica /ID# 270024

    Santa Monica, California, 90404, United States

  • Union Hospital - Tongji Medical College /ID# 268796

    Wuhan, Hubei, 430022, China

  • Universitaetsklinikum Freiburg /ID# 270407

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitaetsklinikum Leipzig /ID# 270432

    Leipzig, Saxony, 04103, Germany

  • Universitair Ziekenhuis Leuven /ID# 269957

    Leuven, Vlaams-Brabant, 3000, Belgium

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