NCT05259696

Glycan Mediated Immune Regulation With a Bi-Sialidase Fusion Protein (GLIMMER-01)

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: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Palleon Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Oncology
• 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

Interventions

Type	Name	Description
BIOLOGICAL	E-602	Subjects will receive E-602 (administered weekly, via IV infusion).
BIOLOGICAL	Cemiplimab	Subjects will receive cemiplimab (administered once every 3 weeks, via IV infusion).

Timeline

• Start date: 2022-02-11
• Primary completion: 2024-10-24
• Completion: 2024-10-24
• First posted: 2022-02-28
• Last updated: 2025-08-20
• Results posted: 2025-08-20

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study