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New targeted drug shows promise for Hard-to-Treat stomach cancers

NCT ID NCT05980416

Disease control Sponsor: Elevation Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested a new drug called EO-3021, which targets a protein (CLDN18.2) found on some cancer cells. The study included 88 adults with advanced stomach or gastrointestinal cancers that had not responded to standard treatments. Participants received EO-3021 alone or combined with other drugs to check safety and early signs of effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EO-3021 (antibody drug conjugate targeting CLDN18.2)
What this could lead to
If successful, this could lead to a new treatment option for advanced stomach and gastrointestinal cancers that express CLDN18.2.
What could go wrong
This is an early Phase 1 trial focused on safety, so it may not show strong anti-cancer effects. The trial was terminated, and results are not yet available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

88 people

The number who actually took part.

Started

Aug 2023

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Availability of tumor tissue for evaluation of biomarker * Patients enrolled to expansion must have tumors expressing CLDN 18.2 based on central prospective IHC testing. * Histologically and/or cytologically confirmed diagnosis of advanced metastatic gastric/GEJ adenocarcinoma not amenable to resection or radiation therapy with curative intent •≥ 18 years of age * ECOG performance status (PS) 0 or 1 at Screening * Progressed on or after standard therapy, or are intolerable of available standard therapy, or there is no available standard therapy * In dose escalation, there is no limit on the number of prior lines of therapy. * In expansion, for EO-3021 monotherapy, at least 1 but no more than 3 prior lines of therapy in the advanced/metastatic setting is allowed * In expansion, for EO-3021 in combination with ramucirumab, only 1 prior line of therapy in the advanced/metastatic setting is allowed. Prior fluoropyrimidine and platinum-containing chemotherapy is required * In expansion, for EO-3021 in combination with dostarlimab, no prior systemic therapy in the advanced/metastatic setting is allowed. * Have at least one measurable extra-cranial lesion as defined by RECIST v1.1 * Adequate organ function * Life expectancy \> 12 weeks * Ability to understand the nature of this study, comply with protocol requirements, and give written informed consent * Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 6 months following study completion (or longer if required by local regulation) Key Exclusion Criteria: * Pregnant or breastfeeding * Symptomatic or untreated brain metastases * Have previously received CLDN18.2 antibody drug conjugates (ADCs) or any ADC containing an auristatin payload (prior monoclonal antibody against CLDN18.2 may be eligible) * Have peripheral neuropathy Grade ≥2 * Have history of non-infectious pneumonitis/interstitial lung disease * Have diagnosis of another malignancy, or history of systemic treatment for invasive cancer within last 3 years. Note: Patients with Stage I cancer who have received definitive local treatment and are considered unlikely to recur are eligible. Diagnosis of non-melanoma skin cancer, carcinoma in situ of the cervix or breast, or noninvasive tumor does not affect eligibility * Have active ocular surface disease at baseline (based on screening ophthalmic examination) as defined as symptomatic or Grade ≥2 disease involving the cornea * Have history of Grade ≥2 gastritis * Have serious concurrent illness or clinically relevant active bacterial, fungal or viral infection * Have a history of several allergic and/or anaphylactic reactions to known chimeric, human, or humanized antibodies, fusion proteins or known allergies to components of EO-3021, ramucirumab, or dostarlimab * Clinically significant cardiac disease, including but not limited to symptomatic congestive heart failure, unstable angina, acute myocardial infarction within 6 months of planned first dose, or unstable cardiac arrhythmia requiring therapy (including torsades de pointes) * Have history of allogenic hematopoietic stem cell transplantation or solid organ transplantation with ongoing systemic immunosuppressive therapy * Received any live vaccine within 30 days of enrollment * Patients who are not appropriate candidates for participation in this clinical study for any other reason as deemed by the Investigator * Expansion only: Have HER2+ disease as defined by American Society of Clinical Oncology-College of American Pathologists guidelines for gastric/GEJ adenocarcinoma * Ramucirumab Arms Only: Received prior treatment with ramucirumab and other VEGFR2 inhibitors * Dostarlimab Arms Only: Prior treatment with immune checkpoint inhibitors (ICI) including dostarlimab and other anti-PD-1, anti-PD-L1, etc.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma digestive system neoplasm Digestive System Neoplasms gastric neoplasm neoplasm Neoplasms by Site

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Digestive system neoplasm Gastrointestinal neoplasms Neoplasms Neoplasms by site Stomach neoplasm

Contacts and locations

Locations

  • Atrium Health/Wake Forest University

    Charlotte, North Carolina, 28204, United States

  • City of Hope

    Duarte, California, 91010, United States

  • Georgetown University

    Washington D.C., District of Columbia, 20007, United States

  • Henry Ford Cancer

    Detroit, Michigan, 48202, United States

  • Johns Hopkins University - Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230, United States

  • Mayo Clinic

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • National Cancer Center Hospital

    Chuo Ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • START Midwest

    Grand Rapids, Michigan, 49546, United States

  • Samsung Medical Center

    Seoul, South Korea

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute at Florida Cancer Specialists

    Orlando, Florida, 32827, United States

  • UW Carbone Cancer Center - Cancer Connect

    Madison, Wisconsin, 53792, United States

  • Yale - Smilow Cancer Hospital

    New Haven, Connecticut, 06519, United States

  • Yonsei University

    Seoul, South Korea

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