Trial Title:
Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2
NCT ID:
NCT05980416
Condition:
Pancreas Neoplasm
Stomach Neoplasm
Gastrointestinal Neoplasms
Digestive System Neoplasm
Neoplasms by Site
Neoplasms
Conditions: Official terms:
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Pancreatic Neoplasms
Conditions: Keywords:
Gastric Cancer
Gastroesophageal Junction (GEJ) Adenocarcinoma
Esophageal Cancer
Pancreatic Cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
EO-3021
Description:
Anti-Claudin 18.2 antibody drug conjugate
Arm group label:
Part A: Escalation
Arm group label:
Part B Expansion
Summary:
This study is an open-label, international, multi-center, Phase 1 study in adult patients
with solid tumors likely to express CLDN18.2.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mitesh Borad, MD
Phone:
480-342-6075
Email:
hunyh.john2@mayo.edu
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dani Castillo, MD
Phone:
877-467-3411
Email:
dacastillo@coh.org
Facility:
Name:
Yale - Smilow Cancer Hospital
Address:
City:
New Haven
Zip:
06519
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ingrid Palma
Phone:
203-833-1034
Email:
ingrid.palma@yale.edu
Facility:
Name:
Georgetown University
Address:
City:
Washington
Zip:
20007
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christina Benedict
Phone:
202-444-2223
Email:
cnb54@georgetown.edu
Facility:
Name:
Johns Hopkins University - Sibley Memorial Hospital
Address:
City:
Washington
Zip:
20016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael (Mike) Pishvaian, MD
Phone:
202-660-6500
Email:
mpishva1@jhmi.edu
Facility:
Name:
Mayo Clinic
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hani Babiker, MD
Phone:
904-953-4888
Email:
Nussbaum.Samuel@mayo.edu
Facility:
Name:
Sarah Cannon Research Institute at Florida Cancer Specialists
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cesar Perez-Batista, MD
Phone:
689-216-8500
Email:
Cesar.PerezBatista@flcancer.com
Facility:
Name:
Henry Ford Cancer
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shipra Puri
Phone:
313-556-8729
Email:
spuri1@hfhs.org
Investigator:
Last name:
Gazala Khan, MD
Email:
Principal Investigator
Facility:
Name:
START Midwest
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Spagnuolo
Phone:
616-954-5552
Email:
ashley.spagnuolo@startmidwest.com
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nguyen Tran, MD
Phone:
507-538-0270
Email:
Hamann.Lucas@mayo.edu
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Steven Maron, MD
Phone:
646-888-6780
Facility:
Name:
Atrium Health/Wake Forest University
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carrie Chiluck
Phone:
980-442-2000
Email:
carrie.chiluck@atriumhealth.org
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Meredith Pelster, MD, MSCI
Facility:
Name:
Mary Crowley Cancer Research
Address:
City:
Dallas
Zip:
75230
Country:
United States
Status:
Recruiting
Contact:
Last name:
Minal Barve, MD
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jenny Li, MD
Email:
GIClinicalTrials@mdanderson.org
Facility:
Name:
UW Carbone Cancer Center - Cancer Connect
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cancer Connect
Phone:
800-622-8922
Email:
cancerconnect@uwcarbone.wisc.edu
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Kohei Shitara, MD
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo Ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Hirokazu Shoji, MD
Facility:
Name:
Samsung Medical Center
Address:
City:
Gangnam-Gu
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jeeyun Lee
Phone:
82-2-3410-1779
Email:
jyunlee@skku.edu
Facility:
Name:
Yonsei University
Address:
City:
Seodaemun-gu
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Minkyu Jung
Phone:
82-2-2228-8128
Email:
MINKJUNG@YUHS.AC
Start date:
August 10, 2023
Completion date:
December 2028
Lead sponsor:
Agency:
Elevation Oncology
Agency class:
Industry
Source:
Elevation Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05980416
