AzTrials
AzTrials

Stomach NeoplasmPhase 1NCT05980416

Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2

A Phase 1 study testing EO-3021, Ramucirumab (CYRAMZA®) and Dostarlimab in people with Stomach Neoplasm and Gastrointestinal Neoplasms, run by Elevation Oncology at 20 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study is an open-label, international, multi-center, Phase 1 study in adult patients with solid tumors likely to express CLDN18.2. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
EO-3021, Ramucirumab (CYRAMZA®) and Dostarlimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
20 sitesin 3 countries
Study dates
10 Aug 2023to 2 Jun 2025
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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)

Who cannot join

  • 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
Show all 17Show fewer
  • 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.

Trial locations and contacts

20 sites in 3 countries.

20 sites in 3 countries

United States16 sites

  • Atrium Health/Wake Forest University

    Charlotte, North Carolina, 28204

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

  • Henry Ford Cancer

    Detroit, Michigan, 48202

  • City of Hope

    Duarte, California, 91010

  • START Midwest

    Grand Rapids, Michigan, 49546

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • UW Carbone Cancer Center - Cancer Connect

    Madison, Wisconsin, 53792

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Yale - Smilow Cancer Hospital

    New Haven, Connecticut, 06519

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Sarah Cannon Research Institute at Florida Cancer Specialists

    Orlando, Florida, 32827

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Georgetown University

    Washington D.C., District of Columbia, 20007

  • Johns Hopkins University - Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

Other trials in United States

Japan2 sites

  • National Cancer Center Hospital

    Chuo Ku, Tokyo, 104-0045

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

Other trials in Japan

South Korea2 sites

  • Samsung Medical Center

    Seoul

  • Yonsei University

    Seoul

Other trials in South Korea

About this study

Official title: A Phase 1 Dose Escalation and Expansion Study of EO-3021, an Anti-claudin 18.2 (CLDN18.2) Antibody Drug Conjugate, in Patients With Solid Tumors Likely to Express CLDN18.2

This study is an open-label, international, multi-center, Phase 1 study in adult patients with solid tumors likely to express CLDN18.2.

Being tested
EO-3021, Ramucirumab (CYRAMZA®), Dostarlimab
Keywords
Gastric Cancer, Gastroesophageal Junction (GEJ) Adenocarcinoma
Medical subject headings
Stomach Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EO-3021Drug

    Anti-Claudin 18.2 antibody drug conjugate

  • Ramucirumab (CYRAMZA®)Drug

    VEGFR2 inhibitor

  • DostarlimabDrug

    anti-PD-1 antibody

Study groups in NCT05980416
Study groupRoleWhat they receive
EO-3021 MonotherapyExperimentalIn escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 monotherapy at various doses every 3 weeks to determine MTD/RP2D(s). In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who have received one and no more than three lines of prior systemic therapy in the advanced metastatic setting will be randomized to one of two doses of EO-3021 dosed every 3 weeks to confirm RP2D.
Receives: Drug: EO-3021
EO-3021 in combination with ramucirumabExperimentalIn escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 at various doses in combination with ramucirumab every 3 weeks to determine MTD/RP2D(s). In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who have received only one prior systemic therapy in the advanced metastatic setting will be treated with EO-3021 in combination with ramucirumab every 3 weeks to confirm RP2D.
Receives: Drug: EO-3021; Drug: Ramucirumab (CYRAMZA®)
EO-3021 in combination with dostarlimabExperimentalIn escalation, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma will receive EO-3021 at various doses in combination with dostarlimab every 3 weeks to determine MTD/RP2D(s). In expansion, adult patients with advanced unresectable or metastatic gastric/GEJ adenocarcinoma expressing CLDN18.2 who have not received any prior systemic therapies in the advanced metastatic setting will be treated with EO-3021 in combination with dostarlimab every 3 weeks to confirm RP2D.
Receives: Drug: EO-3021; Drug: Dostarlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With Treatment Emergent Adverse Events When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab.

    Measured: From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose)

  2. The Incidence Rate of Dose Limiting Toxicities (DLT) During the First 21-day Cycle of Treatment With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab.

    Measured: The first 21-day treatment cycle for each patient enrolled in the Escalation Phase

  3. Number of Patients With Serious Adverse Events When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab.

    Measured: From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose)

  4. Number of Patients With Clinically Significant Changes to Vital Signs When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab

    Measured: From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose

  5. Number of Patients With Clinically Significant Changes in Laboratory Tests When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab.

    Measured: From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose)

  6. The Estimate of Overall Response Rate (ORR) for the Efficacy Population.

    Tumor assessments were evaluated at baseline by computerized tomography (CT) or magnetic resonance imaging (MRI). The primary objective of this study was to determine the overall objective response rate (ORR) per investigator assessment, defined as confirmed complete response (CR; disappearance of all target lesions) + partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) by RECIST v1.1.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2023
  2. Study start10 Aug 2023
  3. Primary completion7 May 2025
  4. Study completion2 Jun 2025

Why it stopped: Business Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05980416
Sponsor's protocol ID
ELVCAP-002-01
Status last verified
Oct 2025
First submitted
31 Jul 2023
Last updated
14 Nov 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing EO-3021, Ramucirumab (CYRAMZA®) and Dostarlimab in people with Stomach Neoplasm and Gastrointestinal Neoplasms, run by Elevation Oncology at 20 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Treatment Emergent Adverse Events When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab. (time frame: From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05980416.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in