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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Title:

Elevation Oncology Receives Fast Track Designation from the FDA for EO-3021 for the Treatment of Adult Patients with Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Expressing Claudin 18.2

Published date:
09/23/2024
Excerpt:
Elevation Oncology...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to EO-3021, a differentiated antibody drug conjugate (ADC), for the treatment of patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2 that has progressed on or after prior therapy.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study of SYSA1801 in the Treatment of Claudin( CLDN) 18.2 Positive Advanced Malignant Solid Tumor

Excerpt:
...Subjects with locally advanced unresectable or metastatic malignant solid tumors confirmed by histology and/or cytology and CLDN 18.2 positive expression in the tumor tissue confirmed by the central laboratory: dose-escalation phase defined as IHC ≥ 1+ by central laboratory IHC assay; dose-expansion phase and extension cohort studies defined as CLDN18.2 expression in ≥ 40% of tumor cells, the IHC ≥ 2+); 4....
Trial ID: