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Treatment with EO-3021 for adults with certain solid tumors

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

Phase 1 Interventional Elevation Oncology · NCT05980416

This study is testing a new drug called EO-3021 to see if it can help adults with advanced solid tumors, like gastric or pancreatic cancer, who have run out of other treatment options.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment120 (estimated)
Ages18 Years and up
SexAll
SponsorElevation Oncology Industry-sponsored
Locations20 sites (Phoenix, Arizona and 19 other locations)
Trial IDNCT05980416 on ClinicalTrials.gov

What this trial studies

This is an open-label, international, multi-center Phase 1 study evaluating the safety and efficacy of EO-3021 in adult patients with advanced solid tumors likely to express CLDN18.2, including gastric, pancreatic, and esophageal cancers. Participants must have progressed on standard therapies or have no available standard treatment options. The study aims to assess the drug's impact on tumor response and overall patient health through careful monitoring and evaluation of measurable lesions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced or metastatic solid tumors that are likely to express CLDN18.2 and have limited treatment options.

Not a fit: Patients who are pregnant, breastfeeding, or have untreated symptomatic brain metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with solid tumors expressing CLDN18.2.

How similar studies have performed: Other studies targeting CLDN18.2 have shown promise, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Availability of tumor tissue (archived and fresh tumor biopsy, if medically feasible)
* Select advanced or metastatic solid tumor that is likely to express CLDN18.2 such as gastric/GEJ, pancreatic and esophageal cancer
* ≥ 18 years of age
* ECOG performance status (PS) 0 or 1 at Screening
* Progressed on or after standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy
* 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 3 months following study completion

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)
* Have serious concurrent illness or clinically relevant active bacterial, fungal or viral infection
* Have previous hypersensitivity to any known components of EO-3021 or history of severe infusion reaction or hypersensitivity (CTCAE Grade 3 or higher) with monoclonal antibody treatment
* 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
* Patients who are not appropriate candidates for participation in this clinical study for any other reason as deemed by the Investigator

Where this trial is running

Phoenix, Arizona and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pancreas NeoplasmStomach NeoplasmGastrointestinal NeoplasmsDigestive System NeoplasmNeoplasms by SiteNeoplasmsGastric CancerGastroesophageal Junction Adenocarcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.