This is a Phase 1/2, first-in-human, open-label, dose escalation and dose-expansion study of E-602, administered alone and in combination with cemiplimab.
This study is being conducted to evaluate the safety, tolerability, PK, pharmacodynamics, and antitumor activity of E-602 in subjects with advanced cancers. Phase 1 of the study consists of dose escalation cohorts of E-602 as a monotherapy and in combination with cemiplimab. Dose escalation will utilize a modified 3+3 design. Any Phase 1 cohort may be backfilled, up to a total of 15 subjects to obtain additional safety, PK, and pharmacodynamic data at a particular dose level. Phase 1 will treat subjects with melanoma, ovarian cancer, non-small cell lung cancer (NSCLC), colorectal cancer, pancreatic cancer, breast cancer, gastric/esophagogastric junction (EGJ) cancer, head and neck cancer, or urothelial cancer. The safety and pharmacodynamic data will be evaluated to identify the maximum tolerated dose and recommended Phase 2 dose level for E-602 as monotherapy and in combination with cemiplimab. Phase 2 consists of dose-expansion disease cohorts in subjects with 3 types of advanced tumors: melanoma, NSCLC, and a third type to be determined (ovarian, colorectal, pancreatic, breast, gastric/EGJ, head and neck, or urothelial) based on available data. Phase 2 includes cohorts of E-602 as monotherapy and E-602 in combination with cemiplimab. For each cohort in Phase 2, Simon's minimax 2-stage design will be used. The study is seeking to enroll a total of up to 273 subjects (up to 87 in Phase 1 and up to 186 in Phase 2). Subjects will participate in the study for about 16 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Subjects will receive E-602 (administered weekly, via IV infusion).
Subjects will receive cemiplimab (administered once every 3 weeks, via IV infusion).
UC San Diego Moores Cancer Center
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
Stanford Health Care
Stanford, California, United States
Yale University Cancer Center
New Haven, Connecticut, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
START Midwest
Grand Rapids, Michigan, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Columbia University
New York, New York, United States
Providence Cancer Institute
Portland, Oregon, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
...and 3 more locations
Number of Participants Who Experienced AEs or SAEs
Number of participants who experienced an adverse events (AEs) or a serious adverse event (SAE)
Time frame: 15 Months
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