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
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)
3 other identifiers
interventional
185
11 countries
49
Brief 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 (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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2024
Longer than P75 for phase_2
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2024
CompletedFirst Posted
Study publicly available on registry
October 4, 2024
CompletedStudy Start
First participant enrolled
December 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2030
July 21, 2026
July 1, 2026
5.8 years
October 3, 2024
July 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Through Study Completion, Approximately 6 Years
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.
Through Study Completion, Approximately 6 Years
Secondary Outcomes (3)
Percentage of Participants Achieving Disease Control (DC) as Assessed by Investigator
Through Study Completion, Approximately 6 Years
Duration of Response (DOR) as Assessed by Investigator
Through Study Completion, Approximately 6 Years
Overall Survival (OS)
Through Study Completion, Approximately 6 Years
Study Arms (4)
Stage 1: Dose Escalation ABBV-400
EXPERIMENTALParticipants 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.
Stage 2 Arm 1: Dose Optimization ABBV-400 Dose A
EXPERIMENTALParticipants 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.
Stage 2 Arm 2: Dose Optimization ABBV-400 Dose B
EXPERIMENTALParticipants 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.
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.
Interventions
IV Infusion
IV Infusion; IV Injection
IV Infusion; IV Injection
Intravenous (IV) Infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (49)
City of Hope National Medical Center /ID# 268690
Duarte, California, 91010, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 272630
Irvine, California, 92618, United States
UCLA - Santa Monica /ID# 270024
Santa Monica, California, 90404, United States
AdventHealth Orlando /ID# 268561
Orlando, Florida, 32803, United States
City Of Hope - Atlanta /ID# 280646
Newnan, Georgia, 30265, United States
Hattiesburg Clinic /ID# 268572
Hattiesburg, Mississippi, 39401, United States
Duke University Medical Center /ID# 268186
Durham, North Carolina, 27710, United States
Millennium Physicians /ID# 268540
Houston, Texas, 77090, United States
Algemeen Ziekenhuis klina /ID# 268754
Brasschaat, Antwerpen, 2930, Belgium
Universitair Ziekenhuis Leuven /ID# 269957
Leuven, Vlaams-Brabant, 3000, Belgium
CHU de Liege /ID# 270223
Liège, 4000, Belgium
Princess Margaret Cancer Centre /ID# 268277
Toronto, Ontario, M5G 2M9, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 268763
Montreal, Quebec, H2X 0C1, Canada
Jewish General Hospital /ID# 268413
Montreal, Quebec, H3T 1E2, Canada
Beijing Cancer Hospital /ID# 268455
Beijing, Beijing Municipality, 100142, China
Cancer Hospital Chinese Academy of Medical Sciences(Langfang) /ID# 277479
Langfang, Hebei, 065000, China
Harbin Medical University Cancer Hospital /ID# 268452
Harbin, Heilongjiang, 150081, China
Union Hospital - Tongji Medical College /ID# 268796
Wuhan, Hubei, 430022, China
The first Affiliated Hospital, Zhejiang University School of Medicine. /ID# 268782
Hangzhou, Zhejiang, 310003, China
Universitaetsklinikum Freiburg /ID# 270407
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
TUM Klinikum rechts der Isar /ID# 267792
Munich, Bavaria, 81675, Germany
Krankenhaus Nordwest /ID# 268462
Frankfurt am Main, Hesse, 60488, Germany
Universitaetsklinikum Leipzig /ID# 270432
Leipzig, Saxony, 04103, Germany
Haematologisch-Onkologische Praxis Eppendorf /ID# 268024
Hamburg, 20249, Germany
Meir Medical Center /ID# 267998
Kefar Sava, Central District, 4428164, Israel
Soroka Medical Center /ID# 268301
Beersheba, Southern District, 8410101, Israel
Tel Aviv Sourasky Medical Center /ID# 267755
Tel Aviv, Tel Aviv, 6423906, Israel
Shaare Zedek Medical Center /ID# 267752
Jerusalem, 9103102, Israel
Hadassah Medical Center-Hebrew University /ID# 267753
Jerusalem, 91120, Israel
Aichi Cancer Center /ID# 268124
Nagoya, Aichi-ken, 464-8681, Japan
National Cancer Center Hospital East /ID# 268083
Kashiwa-shi, Chiba, 277-8577, Japan
Shizuoka Cancer Center /ID# 268123
Sunto-gun, Shizuoka, 411-8777, Japan
National Cancer Center Hospital /ID# 268648
Chuo-Ku, Tokyo, 104-0045, Japan
The Cancer Institute Hospital Of JFCR /ID# 268656
Koto-ku, Tokyo, 135-8550, Japan
Pan American Center for Oncology Trials - Rio Piedras /ID# 268833
Rio Piedras, 00935, Puerto Rico
Hospital Universitario de Navarra /ID# 270119
Pamplona, Navarre, 31008, Spain
Hospital General Universitario Gregorio Maranon /ID# 270037
Madrid, 28007, Spain
Complexo Hospitalario Universitario de Ourense /ID# 270042
Ourense, 32005, Spain
Hospital Clinico Universitario de Valencia /ID# 270040
Valencia, 46010, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 267672
Kaohsiung City, 807, Taiwan
China Medical University Hospital /ID# 267667
Taichung, 40447, Taiwan
National Cheng Kung University Hospital /ID# 267669
Tainan, 704, Taiwan
National Taiwan University Hospital /ID# 267666
Taipei, 100, Taiwan
Taipei Veterans General Hospital /ID# 267664
Taipei, 112, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 267668
Taoyuan City, 333, Taiwan
Barts Health NHS Trust /ID# 270796
London, Greater London, E1 2ES, United Kingdom
Oxford University Hospital NHS Trust /ID# 274614
Oxford, Oxfordshire, OX3 7LE, United Kingdom
Queen Elizabeth Hospital Birmingham /ID# 271199
Birmingham, B15 2TH, United Kingdom
NHS Tayside Health Board /ID# 270799
Dundee, DD2 1SG, United Kingdom
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2024
First Posted
October 4, 2024
Study Start
December 13, 2024
Primary Completion (Estimated)
October 1, 2030
Study Completion (Estimated)
October 1, 2030
Last Updated
July 21, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.