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

Description

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

Conditions

Pancreas Neoplasm, Stomach Neoplasm, Gastrointestinal Neoplasms, Digestive System Neoplasm, Neoplasms by Site, Neoplasms

Study Overview

Study Details

Study overview

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

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

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

Condition
Pancreas Neoplasm
Intervention / Treatment

-

Contacts and Locations

Phoenix

Mayo Clinic, Phoenix, Arizona, United States, 85054

Duarte

City of Hope, Duarte, California, United States, 91010

New Haven

Yale - Smilow Cancer Hospital, New Haven, Connecticut, United States, 06519

Washington

Georgetown University, Washington, District of Columbia, United States, 20007

Washington

Johns Hopkins University - Sibley Memorial Hospital, Washington, District of Columbia, United States, 20016

Jacksonville

Mayo Clinic, Jacksonville, Florida, United States, 32224

Orlando

Sarah Cannon Research Institute at Florida Cancer Specialists, Orlando, Florida, United States, 32827

Detroit

Henry Ford Cancer, Detroit, Michigan, United States, 48202

Grand Rapids

START Midwest, Grand Rapids, Michigan, United States, 49546

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Elevation Oncology,

Valerie Jansen, MD, PhD, STUDY_DIRECTOR, Elevation Oncology, Inc.

Study Record Dates

2028-12