Elevation Oncology has expanded its Phase I clinical trial of EO-3021 to treat advanced, unresectable or metastatic solid tumours, to Japan.
In conjunction with the trial expansion outside the US, the company has dosed the first subject in the country.
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The multicentre, open-label, dose escalation and expansion trial seeks to assess the tolerability, safety, and initial anti-tumour activity of EO-3021 in patients with solid tumours which are likely to express Claudin 18.2.
Subjects will include those with gastric, gastroesophageal junction, pancreatic or oesophageal cancers.
Assessing the link between Claudin 18.2 expression and objective response rates will be analysed as the trial’s additional goal.
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Elevation Oncology anticipates providing an update on the trial’s progress by mid-year, with more comprehensive findings anticipated in the first half of next year.
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By GlobalDataThis latest development has widened the trial’s scope to include multiple sites in Japan, alongside those already established in the US.
EO-3021, also known as SYSA1801, is a clinical-stage antibody drug conjugate (ADC) targeting Claudin 18.2, a protein often found in certain types of cancer.
It is composed of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) and is coupled to the cytotoxic agent monomethyl auristatin E (MMAE) through a cleavable linker.
The company holds sole rights for the development and marketing of EO-3021 in all territories outside Greater China.
Elevation Oncology chief medical officer Valerie Malyvanh Jansen said: “We are pleased to expand our clinical development efforts outside of the US and into Japan where there is a large number of patients with gastric cancer who could benefit from EO-3021.
“Claudin 18.2 is expressed in most gastric adenocarcinomas and is increasingly recognised as an important therapeutic target, which can be effectively addressed with an antibody drug conjugate (ADC).
“We are excited to have dosed our first patient in Japan, as we continue to execute on our mission of delivering novel, selective cancer therapies that can offer better outcomes to patients.”
