Glycan Mediated Immune Regulation With a Bi-Sialidase Fusion Protein (GLIMMER-01)
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
1 other identifier
interventional
69
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2022
Typical duration for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2022
CompletedStudy Start
First participant enrolled
February 11, 2022
CompletedFirst Posted
Study publicly available on registry
February 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2024
CompletedResults Posted
Study results publicly available
August 20, 2025
CompletedAugust 20, 2025
August 1, 2025
2.7 years
February 11, 2022
July 7, 2025
August 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Experienced AEs or SAEs
Number of participants who experienced an adverse events (AEs) or a serious adverse event (SAE)
15 Months
Study Arms (4)
Dose Escalation - Monotherapy
EXPERIMENTALSubjects 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.
Dose Escalation - Combination
EXPERIMENTALSubjects 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.
Expansion - Monotherapy
EXPERIMENTALSubjects will receive E-602 as monotherapy at the recommended Phase 2 dose determined in Phase 1.
Expansion - Combination
EXPERIMENTALSubjects 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.
Interventions
Subjects will receive E-602 (administered weekly, via IV infusion).
Subjects will receive cemiplimab (administered once every 3 weeks, via IV infusion).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- For cohorts receiving E-602 and cemiplimab combination therapy:
- Prior moderate or severe hypersensitivity to cemiplimab or its formulation
- History of severe (≥ Grade 3) autoimmune complications or discontinuation due to toxicity following treatment with an anti-PD-(L)1 pathway therapy as a monotherapy, with the exception of asymptomatic Grade 3 elevations in lipase and/or amylase not associated with clinical manifestations of pancreatitis.
- Previously received idelalisib.
- History of age-related macular degeneration (AMD).
- Recent surgery, treatment with another investigational agent, active infection, non-healing wound or uncontrolled bleeding/bleeding diathesis.
- Received a vaccine or prior radiotherapy within 14 days prior to Cycle 1 Day 1.
- Prior history of interstitial lung disease that required steroids or ≥ Grade 2 immune-related pneumonitis or has current non-infectious pneumonitis or interstitial lung disease. Subject has a history of ≥Grade 3 radiation pneumonitis, or Grade 2 radiation pneumonitis that has been active within the last 6 months.
- Untreated brain metastases.
- A known primary malignancy that is progressing or has required active treatment within the past 3 years.
- Subject is taking the equivalent of \>10 mg/day oral prednisone or on systemic immunosuppressive therapy.
- Subject has had an allogeneic tissue or organ transplantation.
- History of thromboembolic event unless the event occurred \> 6 months from Cycle 1 Day 1 and the subject is on anti-coagulation treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
University of Southern California
Los Angeles, California, 90033, United States
Stanford Health Care
Stanford, California, 94305, United States
Yale University Cancer Center
New Haven, Connecticut, 06520, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
START Midwest
Grand Rapids, Michigan, 49546, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
Columbia University
New York, New York, 10032, United States
Providence Cancer Institute
Portland, Oregon, 97213, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
NEXT Oncology
San Antonio, Texas, 78229, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Palleon Clinical Development
- Organization
- Palleon Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2022
First Posted
February 28, 2022
Study Start
February 11, 2022
Primary Completion
October 24, 2024
Study Completion
October 24, 2024
Last Updated
August 20, 2025
Results First Posted
August 20, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share