Status:
COMPLETED
Glycan Mediated Immune Regulation With a Bi-Sialidase Fusion Protein (GLIMMER-01)
Lead Sponsor:
Palleon Pharmaceuticals, Inc.
Conditions:
Oncology
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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.
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 esca...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- 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.
- Subject has an active autoimmune disease. The following are not exclusionary: vitiligo, type 1 diabetes, autoimmune endocrinopathies that are stable on hormone replacement therapy, or psoriasis that does not require systemic treatment.
- 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.
Key Trial Info
Start Date :
February 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2024
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT05259696
Start Date
February 11 2022
End Date
October 24 2024
Last Update
August 20 2025
Active Locations (13)
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1
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
2
University of Southern California
Los Angeles, California, United States, 90033
3
Stanford Health Care
Stanford, California, United States, 94305
4
Yale University Cancer Center
New Haven, Connecticut, United States, 06520