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Active, Not Recruiting

NCT Number: NCT06628310

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma Adenocarcinoma Of Esophagus Esophageal Adenocarcinoma Gastroesophageal Junction Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Algemeen Ziekenhuis klina /ID# 268754, Brasschaat, Antwerpen, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telisotuzumab Adizutecan

Drug

Intravenous (IV) Infusion

Other names: ABBV-400

Budigalimab

Drug

IV Infusion

Other names: ABBV-181

Fluorouracil

Drug

IV Infusion; IV Injection

Leucovorin

Drug

IV Infusion; IV Injection

Other names: Folinic Acid

Oxaliplatin

Drug

IV Infusion

Primary outcomes

  1. Progression-Free Survival (PFS) as Assessed by Investigator

    Time frame: Through Study Completion, Approximately 6 Years

    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.

  2. Percentage of Participants with Objective Response (OR) as Assessed by Investigator

    Time frame: Through Study Completion, Approximately 6 Years

    OR is defined as confirmed complete response (CR) or confirmed partial response (PR) as assessed by investigator per RECIST version 1.1.

Secondary outcomes

  1. Percentage of Participants Achieving Disease Control (DC) as Assessed by Investigator

    Time frame: Through Study Completion, Approximately 6 Years

    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.

  2. Duration of Response (DOR) as Assessed by Investigator

    Time frame: Through Study Completion, Approximately 6 Years

    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.

  3. Overall Survival (OS)

    Time frame: Through Study Completion, Approximately 6 Years

    OS is defined as the time from first dose of study drug to the event of death from any cause.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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)

Acronym: AndroMETa-GEA

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Oct 4, 2024
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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