Germany-based Ganymed Pharmaceuticals has completed patient enrolment in its Phase II first-line treatment of patients with CLDN18.2-positive advanced adenocarcinomas of the stomach, the esophagus or the gastroesophageal junction (FAST) clinical trial.
A total of 210 patients were enrolled in the randomised three-arm Phase II FAST clinical trial of the combination of IMAB362 and chemotherapy as first-line therapy in patients with gastroesophageal cancer (GEC).
The trial is designed to assess the efficacy and safety of IMAB362 in combination with the chemotherapy agents epirubicin, oxaliplatin, and capecitabine (EOX) in these patients with CLDN18.2-positive, advanced, unresectable, recurrent or metastatic GEC.
CLDN18.2 expression in patients is being determined using the company's Claudetect18.2 diagnostic test.
The primary endpoints of the trial are progression-free survival and safety of IMAB362 in combination with EOX, while secondary endpoints include median overall survival, time to progression, and objective tumour response rate.
The company intends to report top line results from the Phase II trial at the end of 2015 or early 2016.
Ganymed chief executive officer Dr Özlem Türeci said: "Completion of recruitment of this clinical trial represents a key achievement towards our mission of providing cancer patients with safe and effective new therapies.
"Current therapies show limited effectiveness in only a small fraction of GEC patients and are linked to side-effects.
"By contrast, IMAB362 has the potential of benefiting a much larger segment of patients than current therapies with fewer side effects since its target is expressed in up to 80% of GEC tumours, but is not targetable in healthy cells."
IMAB362 is a first-in-class antibody that is selective and specific for the tight junction protein CLDN18.2, which is expressed in about 80% of gastrointestinal adenocarcinomas, 60% of pancreatic tumours as well as in subsets of lung, ovarian and bile duct cancers.