Elevation Oncology has dosed the first patient in a Phase I clinical trial of the fully human monoclonal antibody EO-3021 to treat advanced solid tumours likely to express Claudin 18.2.
The multi-centre, open-label, dose escalation and expansion study will assess the tolerability, safety, and preliminary anti-tumour activity of EO-3021. It aims to enrol nearly 120 patients.
Patients with advanced unresectable or metastatic gastric, gastroesophageal junction, pancreatic or esophageal cancers are anticipated to be enrolled in the dose escalation portion of the study.
In the expansion part, patients with advanced unresectable or metastatic gastric or gastroesophageal junction cancers will be further assessed using EO-3021.
The study will also evaluate the association of Claudin 18.2 expression and objective response, as an additional objective measure.
Elevation Oncology chief medical officer Valerie Malyvanh Jansen said: “Claudin 18.2 has emerged as a promising therapeutic target in gastric cancer and other solid tumours.
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“Based on preclinical and early clinical data, EO-3021 represents a potentially safer and more effective therapeutic option for patients with advanced solid tumours that likely express Claudin 18.2, including gastric and gastroesophageal junction cancers.
“We look forward to evaluating the potential of EO-3021 and expect to report preliminary data on safety and anti-tumour activity from our Phase I study during the first half of 2025.”
Also known as SYSA1801, the antibody-drug conjugate EO-3021 is site-specifically conjugated to the cytotoxic agent monomethyl auristatin E through a cleavable linker, with a drug-to-antibody ratio of 2.
It delivers a cytotoxic payload to Claudin 18.2-expressing cancer cells directly for increasing anti-tumour activity and reducing payload-associated toxicities.