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

  • STATUS
    Recruiting
  • End date
    Oct 13, 2030
  • participants needed
    180
  • sponsor
    AbbVie
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Updated on 13 February 2025
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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 ABBV-400 is given in combination with Fluorouracil, Leucovorin, and a programmed cell death receptor 1 (PD1) inhibitor (Budigalimab) (AFLB) to adult participants to treat locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEA).

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 fluorouracil, leucovorin, and oxaliplatin (FOLFOX). 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 ABBV-400 within the AFLB regimen until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive AFLB, but with one of two optimized doses of ABBV-400The 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.

Details
Condition Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
Age 18years or above
Clinical Study IdentifierNCT06628310
SponsorAbbVie
Last Modified on13 February 2025

Eligibility

 Yes No Not Sure

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 local or 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
Clear my responses
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