Status:
TERMINATED
Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2
Lead Sponsor:
Elevation Oncology
Collaborating Sponsors:
Eli Lilly and Company
GlaxoSmithKline
Conditions:
Stomach Neoplasm
Gastrointestinal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Key
- Availability of tumor tissue for evaluation of biomarker
- Patients enrolled to expansion must have tumors expressing CLDN 18.2 based on central prospective IHC testing.
- Histologically and/or cytologically confirmed diagnosis of advanced metastatic gastric/GEJ adenocarcinoma not amenable to resection or radiation therapy with curative intent
- •≥ 18 years of age
- ECOG performance status (PS) 0 or 1 at Screening
- Progressed on or after standard therapy, or are intolerable of available standard therapy, or there is no available standard therapy
- In dose escalation, there is no limit on the number of prior lines of therapy.
- In expansion, for EO-3021 monotherapy, at least 1 but no more than 3 prior lines of therapy in the advanced/metastatic setting is allowed
- In expansion, for EO-3021 in combination with ramucirumab, only 1 prior line of therapy in the advanced/metastatic setting is allowed. Prior fluoropyrimidine and platinum-containing chemotherapy is required
- In expansion, for EO-3021 in combination with dostarlimab, no prior systemic therapy in the advanced/metastatic setting is allowed.
- 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 6 months following study completion (or longer if required by local regulation)
- Key
Exclusion
- 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) as defined as symptomatic or Grade ≥2 disease involving the cornea
- Have history of Grade ≥2 gastritis
- Have serious concurrent illness or clinically relevant active bacterial, fungal or viral infection
- Have a history of several allergic and/or anaphylactic reactions to known chimeric, human, or humanized antibodies, fusion proteins or known allergies to components of EO-3021, ramucirumab, or dostarlimab
- 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
- Received any live vaccine within 30 days of enrollment
- Patients who are not appropriate candidates for participation in this clinical study for any other reason as deemed by the Investigator
- Expansion only: Have HER2+ disease as defined by American Society of Clinical Oncology-College of American Pathologists guidelines for gastric/GEJ adenocarcinoma
- Ramucirumab Arms Only: Received prior treatment with ramucirumab and other VEGFR2 inhibitors
- Dostarlimab Arms Only: Prior treatment with immune checkpoint inhibitors (ICI) including dostarlimab and other anti-PD-1, anti-PD-L1, etc.
Key Trial Info
Start Date :
August 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2025
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT05980416
Start Date
August 10 2023
End Date
June 2 2025
Last Update
November 14 2025
Active Locations (20)
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1
Mayo Clinic
Phoenix, Arizona, United States, 85054
2
City of Hope
Duarte, California, United States, 91010
3
Yale - Smilow Cancer Hospital
New Haven, Connecticut, United States, 06519
4
Georgetown University
Washington D.C., District of Columbia, United States, 20007