What is the mechanism of action of this treatment?

Targeted therapies for tumors, such as the CLDN18.2-targeting agent, work by specifically binding to proteins like CLDN18.2 on tumor cells. This binding can inhibit tumor growth, induce cell death, or enhance the effectiveness of other treatments. These therapies are important for patients because they offer a more personalized approach, potentially improving treatment outcomes and reducing side effects compared to traditional chemotherapy.

What side effects are associated with this type of intervention?

Common treatments for tumors that target specific proteins, such as monoclonal antibodies and tyrosine kinase inhibitors, often have side effects including fatigue, nausea, diarrhea, and skin reactions. More serious side effects can include hypertension, liver toxicity, and increased risk of infections. Specific agents may also cause unique adverse events; for example, some targeted therapies can lead to cardiovascular issues like atrial fibrillation or major bleeding. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

Several FDA-approved drugs target specific proteins on tumor cells, similar to the investigational CLDN18.2-targeting agent. For example, trastuzumab (Herceptin) targets the HER2 protein in breast cancer, and pembrolizumab (Keytruda) targets the PD-1 protein in various cancers. These drugs work by binding to specific proteins on the surface of tumor cells, thereby inhibiting tumor growth and progression. Such targeted therapies have revolutionized cancer treatment by providing more precise and effective options compared to traditional chemotherapy.

What other types of research exist?

Promising novel alternatives to CLDN18.2-targeting agents for tumor patients include: 1) GD2-CAR T cell therapy for H3K27M-mutated diffuse midline gliomas, which targets the GD2 protein on tumor cells. 2) ONC201, a selective DRD2 antagonist, for H3 K27M-mutant diffuse midline glioma. 3) Cabozantinib, an oral tyrosine kinase inhibitor, for medullary thyroid cancer targeting multiple kinases including RET and MET. 4) Pembrolizumab and Nivolumab, immune checkpoint inhibitors, for various cancers including small cell lung cancer. These therapies represent cutting-edge approaches in targeting specific tumor markers and enhancing immune response against cancer cells.

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Cancer Vaccine

EO-3021 for Gastrointestinal Cancer

Phase 1

Recruiting

Research Sponsored by Elevation Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for adult patients with solid tumors that have a specific marker called CLDN18.2. The treatment aims to find and destroy cancer cells with this marker. This approach helps target the cancer more precisely without affecting normal cells. CLDN18.2 has been identified as a promising target for cancer therapy, particularly in gastric cancer.

Who is the study for?

Adults with advanced or metastatic solid tumors likely to express CLDN18.2, such as stomach, pancreatic, and esophageal cancers. Participants must be over 18, have a good performance status (able to carry out daily activities), adequate organ function, and agree to use birth control. They should have tried standard treatments without success or cannot tolerate them.

What is being tested?

The trial is testing EO-3021 in patients with certain types of cancer that are expected to show the presence of a protein called CLDN18.2. It's an early-phase study assessing how safe the drug is and how it affects these tumors.

What are the potential side effects?

Specific side effects for EO-3021 aren't listed but may include typical reactions seen with antibody drugs like infusion-related discomfort, allergic reactions, fatigue, nausea, and potential impacts on blood counts leading to increased infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B ExpansionExperimental Treatment1 Intervention

Patients with select advanced unresectable or metastatic solid tumors will receive EO-3021 IV infusion every 3 weeks to confirm the RP2D.

Group II: Part A: EscalationExperimental Treatment1 Intervention

Adult patients with select advanced unresectable or metastatic solid tumors likely to express CLDN18.2 will receive EO-3021 IV infusion at various doses every 3 weeks to determine MTD/RP2D(s).

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Targeted therapies for tumors, such as the CLDN18.2-targeting agent, work by specifically binding to proteins like CLDN18.2 on tumor cells. This binding can inhibit tumor growth, induce cell death, or enhance the effectiveness of other treatments. These therapies are important for patients because they offer a more personalized approach, potentially improving treatment outcomes and reducing side effects compared to traditional chemotherapy.