Astellas Doses First Patient in Phase 3 Study of ASP2138 in CLDN18.2‑positive and HER2‑negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma

Rákkutatás · Gastric cancer

Astellas has enrolled the first patient in a Phase 3 randomized, double‑blind, placebo‑controlled trial of ASP2138 in combination with chemotherapy and pembrolizumab as first‑line treatment for adults with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma whose tumors are CLDN18.2‑positive and HER2‑negative.

Astellas Pharma Inc. has begun a multi‑center Phase 3 trial (NCT07673887) to evaluate the safety and efficacy of the bispecific antibody ASP2138 combined with standard chemotherapy (CAPOX or mFOLFOX6) and the immune checkpoint inhibitor pembrolizumab versus placebo in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that express CLDN18.2 and are HER2‑negative. The study is designed as a randomized, double‑blind, placebo‑controlled trial with the primary endpoints of overall survival and progression‑free survival.

CLDN18.2 is a tight‑junction protein expressed on the surface of many gastric and GEJ tumor cells and represents a promising therapeutic target. A bispecific antibody that links T cells to CLDN18.2‑positive tumor cells may enhance anti‑tumor immune activity. This Phase 3 trial investigates whether adding ASP2138 to standard first‑line therapy can improve survival outcomes in a population with limited treatment options and poor prognosis.

Bizonyítékszint: Feltételezés / hírjelzés. Nincs önálló tudományos bizonyíték.

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