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

NCT05980416 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: ELVCAP-002-01
• Study Type: interventional
• Target: 88
• Locations: 3 countries
• Sites: 20

Brief Summary

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

Conditions

Stomach Neoplasm; Gastrointestinal Neoplasms; Digestive System Neoplasm; Neoplasms by Site; Neoplasms

Keywords

Gastric Cancer; Gastroesophageal Junction (GEJ) Adenocarcinoma

Outcome Measures

Primary Outcomes (6)

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

  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 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.

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

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

  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)

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

  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

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

  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 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.

  Up to 24 months

Study Arms (3)

EO-3021 Monotherapy

EXPERIMENTAL

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.

Drug: EO-3021

EO-3021 in combination with ramucirumab

EXPERIMENTAL

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.

Drug: EO-3021; Drug: Ramucirumab (CYRAMZA®)

EO-3021 in combination with dostarlimab

EXPERIMENTAL

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.

Drug: EO-3021; Drug: Dostarlimab

Interventions

EO-3021 DRUG

Anti-Claudin 18.2 antibody drug conjugate

EO-3021 Monotherapy; EO-3021 in combination with dostarlimab; EO-3021 in combination with ramucirumab

Ramucirumab (CYRAMZA®) DRUG

VEGFR2 inhibitor

EO-3021 in combination with ramucirumab

Dostarlimab DRUG

anti-PD-1 antibody

EO-3021 in combination with dostarlimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Elevation Oncology: lead
• Eli Lilly and Company: collaborator
• GlaxoSmithKline: collaborator
• CSPC Pharmaceutical Group Limited: collaborator

Study Sites (20)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

Yale - Smilow Cancer Hospital

New Haven, Connecticut, 06519, United States

Location

Georgetown University

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

Location

Johns Hopkins University - Sibley Memorial Hospital

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

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, 32827, United States

Location

Henry Ford Cancer

Detroit, Michigan, 48202, United States

Location

START Midwest

Grand Rapids, Michigan, 49546, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Atrium Health/Wake Forest University

Charlotte, North Carolina, 28204, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

UW Carbone Cancer Center - Cancer Connect

Madison, Wisconsin, 53792, United States

Location

National Cancer Center Hospital East

Kashiwa-shi, Chiba, 277-8577, Japan

Location

National Cancer Center Hospital

Chuo Ku, Tokyo, 104-0045, Japan

Location

Samsung Medical Center

Seoul, South Korea

Location

Yonsei University

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Adenocarcinoma

Interventions

Ramucirumab; dostarlimab

Condition Hierarchy (Ancestors)

Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Information
• Organization: Elevation Oncology

medinfo@elevationoncology.com

+1-716-371-1125

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 8, 2023
• Study Start: August 10, 2023
• Primary Completion: May 7, 2025
• Study Completion: June 2, 2025
• Last Updated: November 14, 2025
• Results First Posted: November 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2); KR (2); US (16)