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 Genders
- 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
Georgetown University
Washington, District of Columbia 20007
Washington, District of Columbia 20007
More Details
- Status
- Recruiting
- Sponsor
- Elevation Oncology