FDA Grants Fast Track Status to EO-3021 for CLDN18.2-Expressing Gastric or GEJ Cancer

CAR-T Digest - August 2020

24 Sep 2024: FDA Grants Fast Track Status to EO-3021 for CLDN18.2-Expressing Gastric or GEJ Cancer

EO-3021 (SYSA1801) has received fast track designation for advanced or metastatic CLDN18.2-expressing gastric or gastroesophageal junction (GEJ) cancer in patients who have progressed on prior therapies
Initial data from a phase 1 study (NCT05980416) indicated EO-3021 is generally well tolerated, with no grade 4 or 5 toxicities reported among 32 patients. Common adverse effects included nausea (56%) and reduced appetite (47%)
In patients with at least 20% CLDN18.2 expression, the objective response rate (ORR) was 42.8%, with a disease control rate (DCR) of 71.4%
Due to observed dose-limiting toxicities at 2.9 mg/kg, the study will further explore lower doses of 2.0 mg/kg and 2.5 mg/kg administered every 3 weeks in the dose-expansion phase