Actively Recruiting
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
Led by AbbVie · Updated on 2026-03-30
180
Participants Needed
49
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 49 locations
1
City of Hope National Medical Center /ID# 268690
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 272630
Irvine, California, United States, 92618
Actively Recruiting
3
UCLA - Santa Monica /ID# 270024
Santa Monica, California, United States, 90404
Actively Recruiting
4
AdventHealth Orlando /ID# 268561
Orlando, Florida, United States, 32803
Actively Recruiting
5
City Of Hope - Atlanta. /ID# 280646
Newnan, Georgia, United States, 30265
Actively Recruiting
6
Hattiesburg Clinic /ID# 268572
Hattiesburg, Mississippi, United States, 39401
Actively Recruiting
7
Duke University Medical Center /ID# 268186
Durham, North Carolina, United States, 27710
Actively Recruiting
8
Millennium Research & Clinical Development /ID# 268540
Houston, Texas, United States, 77090
Actively Recruiting
9
Algemeen Ziekenhuis klina /ID# 268754
Brasschaat, Antwerpen, Belgium, 2930
Actively Recruiting
10
Universitair Ziekenhuis Leuven /ID# 269957
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
11
CHU de Liege /ID# 270223
Liège, Belgium, 4000
Actively Recruiting
12
Princess Margaret Cancer Centre /ID# 268277
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
13
Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 268763
Montreal, Quebec, Canada, H2X 0C1
Actively Recruiting
14
Jewish General Hospital /ID# 268413
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
15
Beijing Cancer Hospital /ID# 268455
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
16
Cancer Hospital Chinese Academy of Medical Sciences(Langfang) /ID# 277479
Langfang, Hebei, China, 065000
Actively Recruiting
17
Harbin Medical University Cancer Hospital /ID# 268452
Harbin, Heilongjiang, China, 150081
Actively Recruiting
18
Union Hospital - Tongji Medical College /ID# 268796
Wuhan, Hubei, China, 430022
Actively Recruiting
19
The first Affiliated Hospital, Zhejiang University School of Medicine. /ID# 268782
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
20
Universitaetsklinikum Freiburg /ID# 270407
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
21
TUM Klinikum rechts der Isar /ID# 267792
Munich, Bavaria, Germany, 81675
Actively Recruiting
22
Krankenhaus Nordwest /ID# 268462
Frankfurt am Main, Hesse, Germany, 60488
Actively Recruiting
23
Universitaetsklinikum Leipzig /ID# 270432
Leipzig, Saxony, Germany, 04103
Actively Recruiting
24
Haematologisch-Onkologische Praxis Eppendorf /ID# 268024
Hamburg, Germany, 20249
Actively Recruiting
25
Meir Medical Center /ID# 267998
Kfar Saba, Central District, Israel, 4428164
Actively Recruiting
26
Soroka Medical Center /ID# 268301
Beersheba, Southern District, Israel, 8410101
Actively Recruiting
27
Tel Aviv Sourasky Medical Center /ID# 267755
Tel Aviv, Tel Aviv, Israel, 6423906
Actively Recruiting
28
Shaare Zedek Medical Center /ID# 267752
Jerusalem, Israel, 9103102
Actively Recruiting
29
Hadassah Medical Center-Hebrew University /ID# 267753
Jerusalem, Israel, 91120
Actively Recruiting
30
Aichi Cancer Center /ID# 268124
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
31
National Cancer Center Hospital East /ID# 268083
Kashiwa-shi, Chiba, Japan, 277-8577
Actively Recruiting
32
Shizuoka Cancer Center /ID# 268123
Sunto-gun, Shizuoka, Japan, 411-8777
Actively Recruiting
33
National Cancer Center Hospital /ID# 268648
Chuo-Ku, Tokyo, Japan, 104-0045
Actively Recruiting
34
The Cancer Institute Hospital Of JFCR /ID# 268656
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
35
Pan American Center for Oncology Trials /ID# 268833
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
36
Hospital Universitario de Navarra /ID# 270119
Pamplona, Navarre, Spain, 31008
Actively Recruiting
37
Hospital General Universitario Gregorio Maranon /ID# 270037
Madrid, Spain, 28007
Actively Recruiting
38
Complexo Hospitalario Universitario de Ourense /ID# 270042
Ourense, Spain, 32005
Actively Recruiting
39
Hospital Clinico Universitario de Valencia /ID# 270040
Valencia, Spain, 46010
Actively Recruiting
40
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 267672
Kaohsiung City, Taiwan, 807
Actively Recruiting
41
China Medical University Hospital /ID# 267667
Taichung, Taiwan, 40447
Actively Recruiting
42
National Cheng Kung University Hospital /ID# 267669
Tainan, Taiwan, 704
Actively Recruiting
43
National Taiwan University Hospital /ID# 267666
Taipei, Taiwan, 100
Actively Recruiting
44
Taipei Veterans General Hospital /ID# 267664
Taipei, Taiwan, 112
Actively Recruiting
45
Linkou Chang Gung Memorial Hospital /ID# 267668
Taoyuan City, Taiwan, 333
Actively Recruiting
46
Barts Health NHS Trust /ID# 270796
London, Greater London, United Kingdom, E1 2ES
Actively Recruiting
47
Oxford University Hospital NHS Trust /ID# 274614
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Actively Recruiting
48
Queen Elizabeth Hospital Birmingham /ID# 271199
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
49
NHS Tayside Health Board /ID# 270799
Dundee, United Kingdom, DD2 1SG
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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