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
Esophogeal Cancer
Stomach/ Gastric Cancer
Unknown Primary
18 Years and older, Male and Female
M24-977 (primary)
NCI-2024-10331
2024-513008-32
2024-513008-32-00
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.
Eligibility
- 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.
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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