A Phase 1/2, Open-Label, Single-Arm, Dose-Escalation and Dose-Expansion Study of the Safety, Tolerability, Pharmacokinetic, and Antitumor Activity of E-602 as a Single Agent and in Combination With Cemiplimab in Patients With Advanced Cancers
Status: Active_not_recruiting
Location: See all (13) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Subjects with advanced or relapsed/refractory melanoma, ovarian cancer, NSCLC, colorectal cancer, pancreatic cancer, breast cancer, gastric/esophagogastric junction (EGJ) cancer, head and neck cancer, or urothelial cancer who have failed prior therapies.
• a. Subjects with melanoma, NSCLC, head and neck cancer, urothelial cancer, or mMSI-H or dMMR colorectal cancer must have had prior anti-PD-(L)1 pathway therapy and been deemed resistant (had progression on therapy or within 3 months of discontinuation of therapy).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Subject has disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
• Adequate bone marrow, coagulation, renal function, and liver function as determined by laboratory tests
Locations
United States
California
UC San Diego Moores Cancer Center
La Jolla
University of Southern California
Los Angeles
Stanford Health Care
Stanford
Connecticut
Yale University Cancer Center
New Haven
Massachusetts
Massachusetts General Hospital
Boston
Michigan
START Midwest
Grand Rapids
New York
Roswell Park Comprehensive Cancer Center
Buffalo
Columbia University
New York
Oregon
Providence Cancer Institute
Portland
Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh
Tennessee
Sarah Cannon Research Institute
Nashville
Texas
NEXT Oncology
San Antonio
Virginia
Virginia Cancer Specialists
Fairfax
Time Frame
Start Date:2022-02-11
Completion Date:2025-06
Participants
Target number of participants:273
Treatments
Experimental: Dose Escalation - Monotherapy
Subjects will receive E-602 as monotherapy.~Planned monotherapy dose levels: 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, and 30 mg/kg.
Experimental: Dose Escalation - Combination
Subjects will receive E-602 in combination with cemiplimab.~E-602 dose(s): Will be initiated at dose level(s) that have previously completed dosing and DLT assessments as monotherapy.~Cemiplimab dose: 350 mg.
Experimental: Expansion - Monotherapy
Subjects will receive E-602 as monotherapy at the recommended Phase 2 dose determined in Phase 1.
Experimental: Expansion - Combination
Subjects will receive E-602 in combination with cemiplimab.~E-602 dose: Subjects will receive E-602 at the recommended Phase 2 dose determined in Phase 1 in combination with cemiplimab.~Cemiplimab dose: 350 mg.