TERMINATED

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

Conditions

Stomach Neoplasm Gastrointestinal Neoplasms Digestive System Neoplasm Neoplasms by Site Neoplasms Gastric Cancer Gastroesophageal Junction (GEJ) Adenocarcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2023-08-10

Study Completion:2025-06-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05980416

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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)	* 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 monoclonocal antiboby 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 protiens or known allergiest 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 Ams 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.

Inclusion Criteria

Exclusion 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
* 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)

* 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 monoclonocal antiboby 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 protiens or known allergiest 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 Ams 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.

Contacts and Locations

Study Locations (Sites)

Mayo Clinic

Phoenix, Arizona, 85054

United States

City of Hope

Duarte, California, 91010

United States

Yale - Smilow Cancer Hospital

New Haven, Connecticut, 06519

United States

Georgetown University

Washington, District of Columbia, 20007

United States

Johns Hopkins University - Sibley Memorial Hospital

Washington, District of Columbia, 20016

United States

Mayo Clinic

Jacksonville, Florida, 32224

United States

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, 32827

United States

Henry Ford Cancer

Detroit, Michigan, 48202

United States

START Midwest

Grand Rapids, Michigan, 49546

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Atrium Health/Wake Forest University

Charlotte, North Carolina, 28204

United States

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

United States

Mary Crowley Cancer Research

Dallas, Texas, 75230

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

UW Carbone Cancer Center - Cancer Connect

Madison, Wisconsin, 53792

United States

Collaborators and Investigators

Sponsor: Elevation Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-10

Study Completion Date2025-06-02

Study Record Updates

Study Start Date2023-08-10

Study Completion Date2025-06-02

Terms related to this study

Keywords Provided by Researchers

Gastric Cancer
Gastroesophageal Junction (GEJ) Adenocarcinoma

Additional Relevant MeSH Terms

Stomach Neoplasm
Gastrointestinal Neoplasms
Digestive System Neoplasm
Neoplasms by Site
Neoplasms