Gastric

Trial Protocol ID
USOR 24152: 1L HER2+ G/GEJ Ph3 study of ARTEMIDE-GASTRIC01 in combo with pembro FIL gastric cancer (ARTEMIDE-Gastric01)

Investigator
Shreya Sinha, MD

D702AC00001: A Randomized, Phase III Study of Rilvegostomig in Combination with Fluoropyrimidine and Trastuzumab Deruxtecan versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First line Treatment of HER2-positive Gastric Cancer. (ARTEMIDE-Gastric01)

MOA: Rilvegostomig is a bispecific antibody with an engineered triple-mutant Fc domain targeting PD-1 and TIGIT.

Key Eligibility Criteria:

  • Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ cancer
  • HER2-positive (IHC 3+ or IHC 2+ ISH-positive) on a tumor biopsy
  • Central laboratory confirmed PD-L1 CPS ≥ 1 by PD-L1 expression
  • Subjects with lack of physiological integrity of the upper gastrointestinal tract are excluded
  • Subjects with known partial or total DPD enzyme deficiency are excluded