Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Elevation Oncology
With
Eli Lilly and Company
GlaxoSmithKline
CSPC Pharmaceutical Group Limited
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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.
Clareo Health | Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2
