Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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). |
|
|
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. |
|
Recruiting Locations
Yale - Smilow Cancer Hospital
New Haven, Connecticut 06519
New Haven, Connecticut 06519
Georgetown University
Washington, District of Columbia 20007
Washington, District of Columbia 20007
Johns Hopkins University - Sibley Memorial Hospital
Washington, District of Columbia 20016
Washington, District of Columbia 20016
Mayo Clinic
Jacksonville, Florida 32224
Jacksonville, Florida 32224
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida 32827
Orlando, Florida 32827
START Midwest
Grand Rapids, Michigan 49546
Grand Rapids, Michigan 49546
Memorial Sloan Kettering Cancer Center
New York, New York 10065
New York, New York 10065
Contact:
Steven Maron, MD
646-888-6780
Steven Maron, MD
646-888-6780
Atrium Health/Wake Forest University
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
Sarah Cannon Research Institute
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Contact:
Meredith Pelster, MD, MSCI
Meredith Pelster, MD, MSCI
Mary Crowley Cancer Research
Dallas, Texas 75230
Dallas, Texas 75230
Contact:
Minal Barve, MD
Minal Barve, MD
MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
UW Carbone Cancer Center - Cancer Connect
Madison, Wisconsin 53792
Madison, Wisconsin 53792
More Details
- NCT ID
- NCT05980416
- Status
- Recruiting
- Sponsor
- Elevation Oncology