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Elevation Oncology Narrows EO-3021 Trial to Claudin 18.2-Expressing Patients, Launches Combo Cohorts

NEW YORK – Elevation Oncology said Monday that it has begun prospectively testing gastric cancer patients for claudin (CLDN) 18.2 expression prior to enrolling them to the monotherapy portion of an ongoing Phase I clinical trial of the investigational antibody-drug conjugate EO-3021. 

The firm was previously enrolling all-comers with advanced or metastatic cancers likely to express CLDN 18.2, including gastric, gastroesophageal, pancreatic, or esophageal cancers, then, assessing their tumors' expression levels. Now, the firm is taking a prospective biomarker-selection approach and enrolling only those with CLDN 18.2 expression in at least 25 percent of tumor cells with an immunohistochemistry score of 1, 2, or 3 or more. 

Elevation previously reported data showing that the overall response rate was greatest in this biomarker-selected cohort. It plans to report additional safety and efficacy data from the dose-escalation and expansion portions of the study during the first half of 2025. 

The Boston-based firm also said it has launched a new combination cohort in the same Phase I trial, in which patients with advanced gastric and gastroesophageal junction cancer will receive EO-3021 with either GlaxoSmithKline's PD-1 inhibitor Jemperli (dostarlimab) in the front-line setting or Eli Lilly's VEGFR2 inhibitor Cyramza (ramucirumab) in the second-line setting. 

Elevation plans to report data from the combination cohorts in either the fourth quarter of 2025 or the first quarter of 2026. 

Additionally, the firm said it will file an investigational new drug application seeking permission to begin clinical testing of its HER3-targeted antibody-drug conjugate EO-1022 during 2026. The drug is designed to treat HER3-expressing solid cancers, including breast cancer, EGFR-mutant non-small cell lung cancer, and pancreatic cancer. Elevation plans to present preclinical data on the agent this year. 

Elevation Oncology said it has enough cash, cash equivalents, and marketable securities as of Sept. 30, 2024, to fund its operations into 2026.