Astellas Pharma has dosed the first patient in a Phase 3 study of ASP2138, an investigational bispecific antibody being evaluated as a first-line treatment for certain adults with advanced gastric or gastroesophageal junction adenocarcinoma.
The trial is studying ASP2138 in combination with chemotherapy and pembrolizumab in patients with locally advanced unresectable or metastatic disease whose tumors are Claudin 18.2-positive and HER2-negative.
ASP2138 is administered subcutaneously and is designed to bind both CLDN18.2, a protein expressed on certain tumor cells, and CD3-positive T cells. By binding to the two targets, the therapy is intended to bring cancer-fighting T cells closer to CLDN18.2-expressing tumor cells and activate an anti-tumor response.
The Phase 3 advancement is part of Astellas’ broader research effort in CLDN18.2, a target the company is pursuing through approved treatments and investigational assets.
Gastric and gastroesophageal junction cancers remain difficult to treat, particularly after disease becomes unresectable or metastatic. Astellas said patients with advanced disease receiving current standard treatments not directed at CLDN18.2 generally have median progression-free survival of six to seven months.
The company said it is investigating multiple scientific approaches against CLDN18.2 to better understand how targeting the protein could address differing patient needs.
Tadaaki Taniguchi, Astellas’ chief research and development officer, said enrollment of the first patient is an important milestone for both ASP2138 and the company’s CLDN18.2 research program.
“By advancing multiple scientific approaches, we are building the evidence needed to better understand how CLDN18.2-targeted innovation may help address patient needs,” Taniguchi said.
ASP2138 remains an investigational therapy and has not been approved for use. The Phase 3 trial will assess whether adding the bispecific antibody to chemotherapy and pembrolizumab can improve outcomes in patients with CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma.
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