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 (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.