Locally Advanced Unresectable or Metastatic Gastric AdenocarcinomaPhase 2AndroMETa-GEANCT06628310
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
A Phase 2 study testing Telisotuzumab Adizutecan, Budigalimab and Fluorouracil in people with Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by AbbVie at 49 sites in 11 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
- What is being tested?
- Telisotuzumab Adizutecan, Budigalimab and Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 49 sitesin 11 countries
- Study dates
- 13 Dec 2024to Oct 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
49 sites in 11 countries.
49 sites in 11 countries
United States8 sites
City of Hope National Medical Center /ID# 268690
Duarte, California, 91010
Duke University Medical Center /ID# 268186
Durham, North Carolina, 27710
Hattiesburg Clinic /ID# 268572
Hattiesburg, Mississippi, 39401
Millennium Physicians /ID# 268540
Houston, Texas, 77090
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 272630
Irvine, California, 92618
City Of Hope - Atlanta /ID# 280646
Newnan, Georgia, 30265
AdventHealth Orlando /ID# 268561
Orlando, Florida, 32803
UCLA - Santa Monica /ID# 270024
Santa Monica, California, 90404
Taiwan6 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 267672
Kaohsiung City, 807
China Medical University Hospital /ID# 267667
Taichung, 40447
National Cheng Kung University Hospital /ID# 267669
Tainan, 704
National Taiwan University Hospital /ID# 267666
Taipei, 100
Taipei Veterans General Hospital /ID# 267664
Taipei, 112
Linkou Chang Gung Memorial Hospital /ID# 267668
Taoyuan City, 333
China5 sites
Beijing Cancer Hospital /ID# 268455
Beijing, Beijing Municipality, 100142
The first Affiliated Hospital, Zhejiang University School of Medicine. /ID# 268782
Hangzhou, Zhejiang, 310003
Harbin Medical University Cancer Hospital /ID# 268452
Harbin, Heilongjiang, 150081
Cancer Hospital Chinese Academy of Medical Sciences(Langfang) /ID# 277479
Langfang, Hebei, 065000
Union Hospital - Tongji Medical College /ID# 268796
Wuhan, Hubei, 430022
Germany5 sites
Krankenhaus Nordwest /ID# 268462
Frankfurt am Main, Hesse, 60488
Universitaetsklinikum Freiburg /ID# 270407
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Haematologisch-Onkologische Praxis Eppendorf /ID# 268024
Hamburg, 20249
Universitaetsklinikum Leipzig /ID# 270432
Leipzig, Saxony, 04103
TUM Klinikum rechts der Isar /ID# 267792
Munich, Bavaria, 81675
Israel5 sites
Soroka Medical Center /ID# 268301
Beersheba, Southern District, 8410101
Shaare Zedek Medical Center /ID# 267752
Jerusalem, 9103102
Hadassah Medical Center-Hebrew University /ID# 267753
Jerusalem, 91120
Meir Medical Center /ID# 267998
Kefar Sava, Central District, 4428164
Tel Aviv Sourasky Medical Center /ID# 267755
Tel Aviv, Tel Aviv, 6423906
Japan5 sites
National Cancer Center Hospital /ID# 268648
Chuo-Ku, Tokyo, 104-0045
National Cancer Center Hospital East /ID# 268083
Kashiwa-shi, Chiba, 277-8577
The Cancer Institute Hospital Of JFCR /ID# 268656
Koto-ku, Tokyo, 135-8550
Aichi Cancer Center /ID# 268124
Nagoya, Aichi-ken, 464-8681
Shizuoka Cancer Center /ID# 268123
Sunto-gun, Shizuoka, 411-8777
Spain4 sites
Hospital General Universitario Gregorio Maranon /ID# 270037
Madrid, 28007
Complexo Hospitalario Universitario de Ourense /ID# 270042
Ourense, 32005
Hospital Universitario de Navarra /ID# 270119
Pamplona, Navarre, 31008
Hospital Clinico Universitario de Valencia /ID# 270040
Valencia, 46010
United Kingdom4 sites
Queen Elizabeth Hospital Birmingham /ID# 271199
Birmingham, B15 2TH
NHS Tayside Health Board /ID# 270799
Dundee, DD2 1SG
Barts Health NHS Trust /ID# 270796
London, Greater London, E1 2ES
Oxford University Hospital NHS Trust /ID# 274614
Oxford, Oxfordshire, OX3 7LE
Belgium3 sites
Algemeen Ziekenhuis klina /ID# 268754
Brasschaat, Antwerpen, 2930
Universitair Ziekenhuis Leuven /ID# 269957
Leuven, Vlaams-Brabant, 3000
CHU de Liege /ID# 270223
Liège, 4000
Canada3 sites
Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 268763
Montreal, Quebec, H2X 0C1
Jewish General Hospital /ID# 268413
Montreal, Quebec, H3T 1E2
Princess Margaret Cancer Centre /ID# 268277
Toronto, Ontario, M5G 2M9
Puerto Rico1 site
Pan American Center for Oncology Trials - Rio Piedras /ID# 268833
Rio Piedras, 00935
About this study
Official title: 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)
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.
Read more
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
- Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
- Being tested
- Telisotuzumab Adizutecan, Budigalimab, Fluorouracil, Leucovorin, Oxaliplatin
- Keywords
- Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma, ABBV-400, ABBV-181, Budigalimab, Telisotuzumab Adizutecan
- Medical subject headings
- Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telisotuzumab AdizutecanDrug
Also called ABBV-400
Intravenous (IV) Infusion
BudigalimabDrug
Also called ABBV-181
IV Infusion
FluorouracilDrug
IV Infusion; IV Injection
LeucovorinDrug
Also called Folinic Acid
IV Infusion; IV Injection
OxaliplatinDrug
IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: Dose Escalation ABBV-400 | Experimental | 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. Receives: Drug: Telisotuzumab Adizutecan; Drug: Budigalimab; Drug: Fluorouracil; Drug: Leucovorin |
| Stage 2 Arm 1: Dose Optimization ABBV-400 Dose A | Experimental | 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. Receives: Drug: Telisotuzumab Adizutecan; Drug: Budigalimab; Drug: Fluorouracil; Drug: Leucovorin |
| Stage 2 Arm 2: Dose Optimization ABBV-400 Dose B | Experimental | 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. Receives: Drug: Telisotuzumab Adizutecan; Drug: Budigalimab; Drug: Fluorouracil; Drug: Leucovorin |
| Stage 2 Arm 3: Dose Optimization Standard of Care (SOC) | Experimental | Participants will receive a fixed dose of leucovorin (folinic acid), fluorouracil, oxaliplatin (FOLFOX) and budigalimab as part of the approximately 6 year study duration. Receives: Drug: Budigalimab; Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through Study Completion, Approximately 6 Years
Secondary outcomes (3)
Percentage of Participants Achieving Disease Control (DC) as Assessed by Investigator
DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) (with a minimum duration of 14 weeks) based on RECIST, version 1.1 as determined by the investigator.
Measured: Through Study Completion, Approximately 6 Years
Duration of Response (DOR) as Assessed by Investigator
DOR is defined as the time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST version 1.1 as determined by investigator or death from any cause, whichever occurs first.
Measured: Through Study Completion, Approximately 6 Years
Overall Survival (OS)
OS is defined as the time from first dose of study drug to the event of death from any cause.
Measured: Through Study Completion, Approximately 6 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start13 Dec 2024
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Unresectable or Metastatic Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628310
- Sponsor's protocol ID
- M24-977
- Other IDs
- 2024-513008-32, 2024-513008-32-00
- Acronym
- AndroMETa-GEA
- Status last verified
- Jul 2026
- First submitted
- 3 Oct 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.