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

Launched by ABBVIE · Oct 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adults with advanced stomach cancer that cannot be surgically removed or has spread to other parts of the body. The researchers want to see how well a combination of two experimental drugs, ABBV-400 and Budigalimab, works alongside two commonly used cancer drugs, Fluorouracil and Leucovorin. They will also explore the best dose of ABBV-400 that patients can tolerate. The study is divided into two parts: the first will test increasing doses of ABBV-400, and the second will compare different treatment combinations.

To be eligible for this trial, participants must have a confirmed diagnosis of advanced gastric, gastroesophageal junction, or esophageal adenocarcinoma that cannot be treated with surgery. They should be between 65 and 74 years old, in good overall health, and not have previously received certain cancer treatments. Participants can expect to attend regular visits at a hospital or clinic, where they will undergo medical assessments and tests to monitor their health and any side effects. This trial aims to find new and potentially more effective ways to treat this challenging condition.

Gender

ALL

Eligibility 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 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.