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

Neoplasms Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05980416
• Other study ID #: ELVCAP-002-01
• Status: Recruiting
• Phase: Phase 1
• Start date: August 10, 2023
• Est. completion date: December 2028

Study information

• Verified date: March 2024
• Source: Elevation Oncology
• Contact: Medical Information
• Phone: +1-716-371-1125
• Email: medinfo[@]elevationoncology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2028
• Est. primary completion date: September 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

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

Related Conditions & MeSH terms

• Digestive System Neoplasm
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Neoplasms
• Neoplasms by Site
• Pancreas Neoplasm
• Pancreatic Neoplasms
• Stomach Neoplasm
• Stomach Neoplasms

Intervention

Drug:
• EO-3021
Anti-Claudin 18.2 antibody drug conjugate

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	Chuo Ku	Tokyo
Japan	National Cancer Center Hospital East	Kashiwa-shi	Chiba
United States	Mary Crowley Cancer Research	Dallas	Texas
United States	START Midwest	Grand Rapids	Michigan
United States	Mayo Clinic	Jacksonville	Florida
United States	UW Carbone Cancer Center - Cancer Connect	Madison	Wisconsin
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Sarah Cannon Research Institute at Florida Cancer Specialists	Orlando	Florida
United States	Mayo Clinic	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	Johns Hopkins University - Sibley Memorial Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Elevation Oncology

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence rate of dose limiting toxicities (DLT) during the first 21-day cycle of EO-3021 treatment		The first 21-day treatment cycle for each patient enrolled in the Escalation Phase
Primary	Number of patients with treatment emergent adverse events		From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose)
Primary	Number of patients with serious adverse events		From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose)
Primary	Number of patients with clinically significant changes to vital signs		From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose
Primary	Number of patients with clinically significant changes in laboratory tests		From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose)