Abbvie ((ABBV)), Abbvie (($CC:ABBV.CUR)) announced an update on their ongoing clinical study.
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Study Overview: AbbVie is conducting a Phase 2 study titled A Phase 2 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of ABBV-400 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). The study aims to assess the safety and efficacy of ABBV-400, alongside other drugs, in treating advanced gastric cancers, which could significantly impact treatment protocols.
Intervention/Treatment: The study tests the combination of ABBV-400, Budigalimab, Fluorouracil, and Leucovorin. ABBV-400 and Budigalimab are investigational drugs, while Fluorouracil and Leucovorin are established treatments for gastric cancer. The goal is to find the optimal dose of ABBV-400.
Study Design: This interventional study is randomized and follows a sequential intervention model with quadruple masking. The primary purpose is treatment, focusing on determining the best dose of ABBV-400 in combination with other drugs.
Study Timeline: The study began on December 13, 2024, and the last update was submitted on July 29, 2025. The study is expected to run for approximately six years, with key milestones including dose escalation and optimization phases.
Market Implications: This study could influence AbbVie’s stock performance by potentially introducing a new treatment option for gastric cancer, enhancing its oncology portfolio. Positive results may boost investor confidence, while the competitive landscape includes other pharmaceutical companies developing similar treatments.
The study is currently ongoing, with further details available on the ClinicalTrials portal.