This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05980416
Recruitment Status : Recruiting
First Posted : August 8, 2023
Last Update Posted : March 6, 2024
Sponsor:
Information provided by (Responsible Party):
Elevation Oncology

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Pancreas Neoplasm Stomach Neoplasm Gastrointestinal Neoplasms Digestive System Neoplasm Neoplasms by Site Neoplasms Drug: EO-3021 Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 10, 2023
Estimated Primary Completion Date : September 2028
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Part A: Escalation
Adult patients with select advanced unresectable or metastatic solid tumors likely to express CLDN18.2 will receive EO-3021 IV infusion at various doses every 3 weeks to determine MTD/RP2D(s).
 Drug: EO-3021
Anti-Claudin 18.2 antibody drug conjugate
Experimental: Part B Expansion
Patients with select advanced unresectable or metastatic solid tumors will receive EO-3021 IV infusion every 3 weeks to confirm the RP2D.
 Drug: EO-3021
Anti-Claudin 18.2 antibody drug conjugate


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The incidence rate of dose limiting toxicities (DLT) during the first 21-day cycle of EO-3021 treatment [ Time Frame: The first 21-day treatment cycle for each patient enrolled in the Escalation Phase ]
  2. Number of patients with treatment emergent adverse events [ 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) ]
  3. Number of patients with serious adverse events [ 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) ]
  4. Number of patients with clinically significant changes to vital signs [ 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 ]
  5. Number of patients with clinically significant changes in laboratory tests [ 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) ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05980416


Contacts
Layout table for location contacts
Contact: Medical Information +1-716-371-1125 medinfo@elevationoncology.com

Locations
Layout table for location information
United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
Contact: Mitesh Board, MD    480-342-6075    hunyh.john2@mayo.edu   
United States, District of Columbia
Johns Hopkins University - Sibley Memorial Hospital Recruiting
Washington, District of Columbia, United States, 20016
Contact: Michael (Mike) Pishvaian, MD    202-660-6500    mpishva1@jhmi.edu   
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Hani Babiker, MD    904-953-4888    Nussbaum.Samuel@mayo.edu   
Sarah Cannon Research Institute at Florida Cancer Specialists Recruiting
Orlando, Florida, United States, 32827
Contact: Cesar Perez-Batista, MD    689-216-8500    Cesar.PerezBatista@flcancer.com   
United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Ashley Spagnuolo    616-954-5552    ashley.spagnuolo@startmidwest.com   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Nguyen Tran, MD    507-538-0270    Hamann.Lucas@mayo.edu   
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Steven Maron, MD    646-888-6780      
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Meredith Pelster, MD, MSCI         
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75230
Contact: Minal Barve, MD         
United States, Wisconsin
UW Carbone Cancer Center - Cancer Connect Recruiting
Madison, Wisconsin, United States, 53792
Contact: Cancer Connect    800-622-8922    cancerconnect@uwcarbone.wisc.edu   
Japan
National Cancer Center Hospital East Recruiting
Kashiwa-shi, Chiba, Japan, 277-8577
Contact: Kohei Shitara, MD         
National Cancer Center Hospital Recruiting
Chuo Ku, Tokyo, Japan, 104-0045
Contact: Hirokazu Shoji, MD         
Sponsors and Collaborators
Elevation Oncology
Investigators
Layout table for investigator information
Study Director: Valerie Jansen, MD, PhD Elevation Oncology, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Elevation Oncology
ClinicalTrials.gov Identifier: NCT05980416    
Other Study ID Numbers: ELVCAP-002-01
First Posted: August 8, 2023    Key Record Dates
Last Update Posted: March 6, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elevation Oncology:
Gastric Cancer
Gastroesophageal Junction (GEJ) Adenocarcinoma
Esophageal Cancer
Pancreatic Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Pancreatic Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases