Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2

Launched by ELEVATION ONCOLOGY · Jul 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called EO-3021 for adult patients with certain types of solid tumors, like pancreatic and stomach cancers, that are likely to have a specific protein known as CLDN18.2. The study is currently recruiting participants who are at least 18 years old and have advanced cancer that has progressed despite standard treatments. To join, patients need to provide a sample of their tumor tissue and have a measurable tumor that can be assessed during the trial.

Participants in this trial can expect to receive EO-3021 and be monitored for how well the treatment works and any side effects. They should be in generally good health, with a life expectancy of at least 12 weeks, and should not have certain serious health issues, like untreated brain metastases or recent severe heart problems. It's also important for participants to understand the study and be willing to follow its guidelines, including using effective birth control if they are able to have children. This trial aims to gather more information about the safety and effectiveness of EO-3021, which could lead to new options for patients with these challenging cancers.

Gender

ALL

Eligibility criteria

• 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 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