Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2
NCT ID: NCT05980416
Last Updated: 2025-11-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
88 participants
INTERVENTIONAL
2023-08-10
2025-06-02
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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EO-3021 Monotherapy
In 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.
EO-3021
Anti-Claudin 18.2 antibody drug conjugate
EO-3021 in combination with ramucirumab
In 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.
EO-3021
Anti-Claudin 18.2 antibody drug conjugate
Ramucirumab (CYRAMZA®)
VEGFR2 inhibitor
EO-3021 in combination with dostarlimab
In 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.
EO-3021
Anti-Claudin 18.2 antibody drug conjugate
Dostarlimab
anti-PD-1 antibody
Interventions
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EO-3021
Anti-Claudin 18.2 antibody drug conjugate
Ramucirumab (CYRAMZA®)
VEGFR2 inhibitor
Dostarlimab
anti-PD-1 antibody
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
GlaxoSmithKline
INDUSTRY
CSPC Pharmaceutical Group Limited
INDUSTRY
Elevation Oncology
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic
Phoenix, Arizona, United States
City of Hope
Duarte, California, United States
Yale - Smilow Cancer Hospital
New Haven, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
Johns Hopkins University - Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Mayo Clinic
Jacksonville, Florida, United States
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States
Henry Ford Cancer
Detroit, Michigan, United States
START Midwest
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Atrium Health/Wake Forest University
Charlotte, North Carolina, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
UW Carbone Cancer Center - Cancer Connect
Madison, Wisconsin, United States
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan
Samsung Medical Center
Seoul, , South Korea
Yonsei University
Seoul, , South Korea
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ELVCAP-002-01
Identifier Type: -
Identifier Source: org_study_id