This study is an open-label, international, multi-center, Phase 1 study in adult patients with solid tumors likely to express CLDN18.2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Anti-Claudin 18.2 antibody drug conjugate
VEGFR2 inhibitor
anti-PD-1 antibody
Mayo Clinic
Phoenix, Arizona, United States
City of Hope
Duarte, California, United States
Number of Patients With Treatment Emergent Adverse Events When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab.
Time frame: 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)
The Incidence Rate of Dose Limiting Toxicities (DLT) During the First 21-day Cycle of Treatment With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab.
Time frame: The first 21-day treatment cycle for each patient enrolled in the Escalation Phase
Number of Patients With Serious Adverse Events When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab.
Time frame: 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)
Number of Patients With Clinically Significant Changes to Vital Signs When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab
Time frame: 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
Number of Patients With Clinically Significant Changes in Laboratory Tests When Treated With EO-3021 as Monotherapy and in Combination With Ramucirumab or Dostarlimab.
Time frame: 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)
The Estimate of Overall Response Rate (ORR) for the Efficacy Population.
Tumor assessments were evaluated at baseline by computerized tomography (CT) or magnetic resonance imaging (MRI). The primary objective of this study was to determine the overall objective response rate (ORR) per investigator assessment, defined as confirmed complete response (CR; disappearance of all target lesions) + partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) by RECIST v1.1.
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Yale - Smilow Cancer Hospital
New Haven, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
Johns Hopkins University - Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Mayo Clinic
Jacksonville, Florida, United States
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States
Henry Ford Cancer
Detroit, Michigan, United States
START Midwest
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
...and 10 more locations
Time frame: Up to 24 months