Clinical Trial

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