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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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Telisotuzumab Adizutecan (drug), Budigalimab (drug), Fluorouracil (drug), Leucovorin (drug)
How long the study runs: Study runs about 70 months (dates as stated)
About the drug or intervention: Telisotuzumab Adizutecan — drug: Intravenous (IV) Infusion · Budigalimab — drug: IV Infusion · Fluorouracil — drug: IV Infusion; IV Injection · Leucovorin — drug: IV Infusion; IV Injection · Oxaliplatin — drug: IV Infusion
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years and over
Who: All
Number of participants: 185
Started: 2024-12-13
Last checked: 2026-07

Plain English Summary

What is this study?

• Testing a new treatment for locally advanced unresectable or metastatic gastric adenocarcinoma
• Phase2 - 185 participants
• Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably

Who can take part?

• Ages 18 Years and over
• Diagnosed with locally advanced unresectable or metastatic gastric adenocarcinoma

Where?

• London - Barts Health NHS Trust /ID# 270796
• Oxford - Oxford University Hospital NHS Trust /ID# 274614
• Birmingham - Queen Elizabeth Hospital Birmingham /ID# 271199
• Dundee - NHS Tayside Health Board /ID# 270799

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Locally Advanced Unresectable or Metastatic Gastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaEsophageal Adenocarcinoma

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

Biomarkers mentioned

HER2PD-L1

What the study is looking for

✓Have inoperable, advanced or that has spread histologically- or cytologically confirmed gastric, gastroesophageal...
✓Have cancer that can be measured on scans determined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
✓Have an activity scale (ECOG) performance status (PS) of 0 or 1.
✓Human epidermal growth factor receptor 2 (HER2) negative disease, defined as immunohistochemistry (IHC) (0, or 1+)...
✓Known programmed death ligand 1 (PD-L1) status at screening, or availability of tumor tissue for central PD-L1...

Who cannot take part

✗Have prior treatment that goes through your whole body in the that has grown locally, unresectable, or that has spread setting.
✗History of clinically significant, intercurrent lung-specific illnesses including, but not limited to those listed...

See the full criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.