Title
A Phase 1 Dose Escalation and Expansion Study of EO-3021, an Anti-claudin 18.2 (CLDN18.2) Antibody Drug Conjugate, in Patients with Solid Tumors Likely to Express CLDN18.2

Description
This study is an open-label, international, multi-center, Phase 1 study in adult patients with solid tumors likely to express CLDN18.2

Objective
Primary:
-The primary objective of this study is to determine the single-agent EO-3021 recommended phase 2 dose(s) (RP2D) and schedule for further exploration in patients with advanced solid tumors that are likely to express CLDN18.2.

Secondary:
-To document the overall safety profile for EO-3021 when administered as an IV dose
-To evaluate the PK profile of EO-3021
-To assess the immunogenicity of EO-3021
-To document any early indication of clinical efficacy in patients with advanced solid tumors

Treatment Drug: EO-3021

Key Eligibility 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

Applicable Disease Sites
Anal; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Ill-Defined Sites; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Sarcoma; Uterus

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital