Ensayos clínicos

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 monoclonocal 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/9/23. Questions regarding updates should be directed to the study team contact.