Actively Recruiting
A Phase 2 Randomized Study to Evaluate Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan with Fluorouracil, Leucovorin, and Budigalimab in Adults with Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
Led by AbbVie · Updated on 2026-03-30
180
Participants Needed
49
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety, side effects, and best dose of telisotuzumab adizutecan (ABBV-400) combined with fluorouracil, leucovorin, and the PD-1 inhibitor budigalimab in adults with locally advanced, unresectable, or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEA). This phase 2 study aims to assess disease activity changes and adverse events of this combination treatment in about 180 participants worldwide over approximately six years. The study has two stages. In the first stage, participants receive increasing intravenous doses of ABBV-400 with fixed doses of fluorouracil, leucovorin, and budigalimab until a tolerable and potentially effective dose is found. In the second stage, participants are randomly assigned to one of four groups: one group gets budigalimab with FOLFOX (fluorouracil, leucovorin, oxaliplatin), while the other three groups receive two different optimized doses of ABBV-400 combined with fluorouracil, leucovorin, and budigalimab. Treatment continues as part of the approximately six-year study. Participants will attend regular visits at approved hospitals or clinics throughout the study. Researchers will monitor treatment effects with medical exams, blood tests, questionnaires, and side effect assessments. The main outcomes measured include progression-free survival and response rates, with additional evaluations of disease control, response duration, and overall survival. The study includes close safety monitoring and follow-up during and after treatment.
CONDITIONS
Brief 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...
- Adults with inoperable, advanced, or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma confirmed by tissue tests
- Measurable disease according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- HER2 negative tumor status by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)
- Known PD-L1 status or availability of tumor tissue for PD-L1 testing before enrollment
You will not qualify if you...
- Prior systemic therapy for locally advanced, unresectable, or metastatic disease
- History of significant lung-related illnesses as specified in the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 6 years
Participants receive intravenous doses of telisotuzumab adizutecan combined with fluorouracil, leucovorin, budigalimab, and oxaliplatin according to their assigned dose group over the course of the study.
Regular visits as per treatment schedule during the study period
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
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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