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
NCT ID: NCT06628310
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
180 participants
INTERVENTIONAL
2024-12-13
2030-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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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.
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Budigalimab
IV Infusion
Fluorouracil
IV Infusion; IV Injection
Leucovorin
IV Infusion; IV Injection
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.
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Budigalimab
IV Infusion
Fluorouracil
IV Infusion; IV Injection
Leucovorin
IV Infusion; IV Injection
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.
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Budigalimab
IV Infusion
Fluorouracil
IV Infusion; IV Injection
Leucovorin
IV Infusion; IV Injection
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.
Budigalimab
IV Infusion
Fluorouracil
IV Infusion; IV Injection
Leucovorin
IV Infusion; IV Injection
Oxaliplatin
IV Infusion
Interventions
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Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Budigalimab
IV Infusion
Fluorouracil
IV Infusion; IV Injection
Leucovorin
IV Infusion; IV Injection
Oxaliplatin
IV Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* History of clinically significant, intercurrent lung-specific illnesses including, but not limited to those listed in the protocol.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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City of Hope National Medical Center /ID# 268690
Duarte, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 272630
Irvine, California, United States
UCLA - Santa Monica /ID# 270024
Santa Monica, California, United States
Hattiesburg Clinic /ID# 268572
Hattiesburg, Mississippi, United States
Duke University Medical Center /ID# 268186
Durham, North Carolina, United States
Millennium Research & Clinical Development /ID# 268540
Houston, Texas, United States
Algemeen Ziekenhuis klina /ID# 268754
Brasschaat, Antwerpen, Belgium
Centre Hospitalier de l'Université de Montréal (CHUM) /ID# 268763
Montreal, Quebec, Canada
Beijing Cancer Hospital /ID# 268455
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences(Langfang) /ID# 277479
Langfang, Hebei, China
Harbin Medical University Cancer Hospital /ID# 268452
Harbin, Heilongjiang, China
Union Hospital - Tongji Medical College /ID# 268796
Wuhan, Hubei, China
The first Affiliated Hospital, Zhejiang University School of Medicine. /ID# 268782
Hangzhou, Zhejiang, China
TUM Klinikum rechts der Isar /ID# 267792
Munich, Bavaria, Germany
Universitaetsklinikum Leipzig /ID# 270432
Leipzig, Saxony, Germany
Meir Medical Center /ID# 267998
Kfar Saba, Central District, Israel
Soroka Medical Center /ID# 268301
Beersheba, Southern District, Israel
Tel Aviv Sourasky Medical Center /ID# 267755
Tel Aviv, Tel Aviv, Israel
Shaare Zedek Medical Center /ID# 267752
Jerusalem, , Israel
Hadassah Medical Center-Hebrew University /ID# 267753
Jerusalem, , Israel
Aichi Cancer Center /ID# 268124
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East /ID# 268083
Kashiwa-shi, Chiba, Japan
Shizuoka Cancer Center /ID# 268123
Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital /ID# 268648
Chuo-Ku, Tokyo, Japan
The Cancer Institute Hospital Of JFCR /ID# 268656
Koto-ku, Tokyo, Japan
Pan American Center for Oncology Trials /ID# 268833
Rio Piedras, , Puerto Rico
Hospital General Universitario Gregorio Maranon /ID# 270037
Madrid, , Spain
Complexo Hospitalario Universitario de Ourense /ID# 270042
Ourense, , Spain
Hospital Clínico Universitario de Valencia /ID# 270040
Valencia, , Spain
National Taiwan University Hospital /ID# 267666
Taipei City, Taipei, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 267672
Kaohsiung City, , Taiwan
China Medical University Hospital /ID# 267667
Taichung, , Taiwan
National Cheng Kung University Hospital /ID# 267669
Tainan, , Taiwan
Taipei Veterans General Hospital /ID# 267664
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 267668
Taoyuan, , Taiwan
NHS Tayside Health Board /ID# 270799
Dundee, , United Kingdom
Countries
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Central Contacts
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Related Links
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Other Identifiers
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2024-513008-32
Identifier Type: OTHER
Identifier Source: secondary_id
M24-977
Identifier Type: -
Identifier Source: org_study_id