Elevation Oncology has released initial data from the dose escalation section of the ongoing Phase I study of EO-3021, which is targeting patients with advanced solid tumours likely to express Claudin 18.2.
The trial focuses on assessing EO-3021 in treating various cancers, including gastric, gastroesophageal junction (GEJ), pancreatic, and oesophageal cancers.
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As of 10 June 2024, the data cutoff date, 32 patients were treated with EO-3021 across four dose levels in the Phase I trial. Most notably, 26 of them were diagnosed with gastric or GEJ cancer.
According to the findings, the treatment was generally well-tolerated, without any reports of Grade 4 or 5 treatment-related adverse events.
In addition, less than 10% of subjects discontinued the treatment due to adverse events.
No cases of neutropenia or peripheral neuropathy/hypoesthesia were observed among the patients. These conditions are known toxicities associated with monomethyl auristatin E (MMAE), a component often used in cancer therapies, the company noted.
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By GlobalDataNausea, decreased appetite, fatigue, and diarrhoea were the common treatment-emergent adverse events reported across all grades.
Among seven patients with a high expression of Claudin 18.2 in their tumour cells, the objective response rate (ORR) was 42.8%, and the disease control rate (DCR) was 71.4%. This group included two patients who achieved stable disease (SD).
In eight patients with lower expressions of Claudin 18.2, the ORR was reported to be 0%, and the DCR was 50%, which included four patients with SD.
Elevation Oncology chief medical officer Valerie Malyvanh Jansen said: “We are encouraged to see the benefits of EO-3021’s site-specific conjugation translate clinically, with minimal MMAE-associated toxicities observed in our Phase I trial.
“Coupled with the promising anti-tumour activity reported in patients with gastric or GEJ cancer, the data suggest that EO-3021 is a potential best-in-class Claudin 18.2 antibody-drug conjugate.
“We look forward to advancing into monotherapy dose expansion and initiating our combination cohorts in the months ahead, as well as reporting additional data from our ongoing trial in the first half of 2025.”
In February 2024, Elevation Oncology expanded its Phase I clinical trial of EO-3021 to treat advanced, unresectable, or metastatic solid tumours in Japan.
