Elevation Oncology Advances Clinical Trials for Gastric Cancer: Data Updates for 2025

Elevation Oncology has announced updates on its ongoing clinical trials and forthcoming milestones for its advanced cancer treatment candidates, with a focus on EO-3021, a novel antibody drug conjugate (ADC) targeting Claudin 18.2 in gastric and gastroesophageal junction (GEJ) cancers.

Elevation Oncology is an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs.

“We are rapidly advancing EO-3021 to address significant unmet needs in treating earlier lines of advanced gastric/GEJ cancer, where we believe we have a unique ability to improve on the standard of care. As we enter 2025, we are honing our focus, leveraging the competitive anti-tumor activity and differentiated safety profile of EO-3021 to explore combination approaches in the first- and second-line settings.

With our Phase 1 clinical trial ongoing and now enrolling both monotherapy and combination cohorts, we are in a leading position to explore the compelling potential of EO-3021, our differentiated Claudin 18.2 ADC, to improve outcomes for people living with advanced gastric/GEJ cancer,” – said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology.

Program Updates and Upcoming Milestones

EO-3021: Elevation Oncology is advancing EO-3021, a potentially best-in-class antibody-drug conjugate (ADC) aimed at treating patients with advanced, unresectable, or metastatic solid tumors that are likely to express Claudin 18.2, particularly gastric and gastroesophageal junction (GEJ) cancers.

In August 2024, the company reported promising initial monotherapy results from the dose escalation phase of its ongoing Phase 1 clinical trial, showing a confirmed overall response rate (ORR) of 42.8% in a biomarker-enriched cohort. The safety profile is noteworthy, with minimal hematological and hepatotoxicity reported, and no cases of peripheral neuropathy or hypoesthesia.

Based on these findings, Elevation Oncology is concentrating its clinical development efforts for EO-3021 on first- and second-line treatments for advanced gastric/GEJ cancer, where the drug’s characteristics may offer significant benefits in patient outcomes and safety.

Monotherapy:

The dose expansion phase of the Phase 1 trial for EO-3021 is currently underway. As of January 2025, the company has begun implementing prospective Claudin 18.2 expression testing during patient screening, targeting those with at least 25% of tumor cells expressing IHC 1+/2+/3+. Additional safety and efficacy data from both the dose escalation and expansion phases are expected in the first half of 2025.

Combination:

Patient dosing is also ongoing in the combination phase of the trial, evaluating EO-3021 alongside dostarlimab, a PD-1 inhibitor, in first-line treatment and with ramucirumab, a VEGFR2 inhibitor, in second-line treatment. The combination with dostarlimab aims to provide synergistic benefits that could enhance patient outcomes compared to existing immunotherapy and chemotherapy combinations used in front-line gastric/GEJ cancer treatment. Similarly, the combination with ramucirumab seeks to improve tolerability and anti-tumor activity compared to the standard ramucirumab plus paclitaxel regimen for second-line treatment.

Elevation Oncology anticipates reporting initial data from these combination cohorts in late 2025 or early 2026.

EO-1022: The company is also developing EO-1022, a differentiated HER3 ADC targeting solid tumors that express HER3, including breast cancer and EGFR-mutant non-small cell lung cancer. EO-1022 combines seribantumab, a fully human anti-HER3 monoclonal antibody, with a monomethyl auristatin E (MMAE) payload using site-specific conjugation technology. This design aims to leverage seribantumab’s internalization capability while delivering an effective treatment option for patients with HER3-expressing solid tumors.

Elevation Oncology plans to present preclinical data for EO-1022 in the first half of 2025 and intends to file an IND application in 2026.

“We look forward to sharing additional data from our Phase 1 dose escalation and expansion study of EO-3021 in the first half of 2025. With this readout, we aim to build on the promising initial data reported in August 2024, reinforcing EO-3021’s robust anti-tumor activity and potential better combinability, while garnering additional insights to inform our go-forward clinical development efforts. We are enthusiastic about the potential of EO-3021 in addressing meaningful market opportunities and look forward to a transformative 2025,” – said Joseph Ferra.

About Elevation Oncology

Elevation Oncology is a biotechnology company based in Boston, Massachusetts, focused on developing targeted cancer therapies for solid tumors. Founded in 2019 and publicly listed since June 2021, the company aims to address significant unmet medical needs in oncology.

Elevation’s primary therapeutic candidate is EO-3021, an antibody-drug conjugate targeting Claudin 18.2, which is expressed in certain cancers. Currently in Phase 1 clinical trials, EO-3021 is being evaluated for advanced solid tumors, including gastric and gastroesophageal junction cancers. The company is also advancing a second program targeting HER3, with plans to nominate a development candidate in 2024. Elevation Oncology is positioned as a promising player in the oncology field, leveraging precision medicine to develop targeted treatments for cancer patients.

Further Reading:

Immunotherapy for Gastrointestinal Cancer

Stomach Cancer: Symptoms and Causes, Types, Diagnosis and Treatment