At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 69 enrolled
Drug / intervention
E-602 +1 morebiological
Likely dose
E-602 weekly via IV infusion; cemiplimab once every 3 weeks via IV infusionAI-extracted
Key inclusion· 5
- ✓Advanced or relapsed/refractory melanoma, ovarian cancer, NSCLC, colorectal cancer, pancreatic cancer, breast cancer, gastric/esophagogastric junction cancer, head and neck cancer, or urothelial cancer with prior therapy failure
- ✓Melanoma, NSCLC, head and neck, urothelial, or mMSI-H/dMMR colorectal cancer patients must have prior anti-PD-(L)1 therapy with documented resistance (progression on or within 3 months of discontinuation)
- ✓ECOG performance status 0 or 1
- ✓Measurable disease by RECIST v1.1
Key exclusion· 13
- ✕For combination cohorts: prior moderate or severe hypersensitivity to cemiplimab or its formulation
- ✕For combination cohorts: severe (≥Grade 3) autoimmune complications or discontinuation due to toxicity from anti-PD-(L)1 therapy (except asymptomatic Grade 3 lipase/amylase elevations without pancreatitis)
- ✕For combination cohorts: active autoimmune disease (except vitiligo, type 1 diabetes, stable autoimmune endocrinopathies on hormone replacement, or psoriasis without systemic treatment)
- ✕For combination cohorts: prior receipt of idelalisib
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating E-602 and Cemiplimab for Oncology and 16 related conditions. Completed, enrolled 69 participants across 13 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOncology, Melanoma, Ovarian Cancer, NSCLC, Non Small Cell Lung Cancer, Colorectal Cancer, Pancreatic Cancer, Cancer, CRC, Colon Cancer, Breast Cancer, Gastric Cancer, EGJ, Esophagogastric Junction Cancer, Head and Neck Cancer, Urothelial Cancer, Bladder Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
Enrollment StartFeb 2022
First PostedFeb 2022
Primary CompletionOct 2024
TodayJul 2026
First PostedFeb 28, 2022
Enrollment StartFeb 11, 2022
Primary CompletionOct 24, 2024
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 4.3 years ago
Interventions
E-602biological
Subjects will receive E-602 (administered weekly, via IV infusion).
Cemiplimabbiological
Subjects will receive cemiplimab (administered once every 3 weeks, via IV infusion).