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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• 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

ELIGIBILITY

Key Inclusion Criteria:
1. 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).

- 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- 3. Subject has disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.

- 4. Adequate bone marrow, coagulation, renal function, and liver function as determined by laboratory tests
Key Exclusion Criteria:
1. For cohorts receiving E-602 and cemiplimab combination therapy:
1. Prior moderate or severe hypersensitivity to cemiplimab or its formulation

- 2. 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.

- 3. 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.

- 4. Previously received idelalisib.

- 2. History of age-related macular degeneration (AMD).

- 3. Recent surgery, treatment with another investigational agent, active infection, non-healing wound or uncontrolled bleeding/bleeding diathesis.

- 4. Received a vaccine or prior radiotherapy within 14 days prior to Cycle 1 Day 1.

- 5. 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.

- 6. Untreated brain metastases.

- 7. A known primary malignancy that is progressing or has required active treatment within the past 3 years.

- 8. Subject is taking the equivalent of >10 mg/day oral prednisone or on systemic immunosuppressive therapy.

- 9. Subject has had an allogeneic tissue or organ transplantation.

- 10. History of thromboembolic event unless the event occurred > 6 months from Cycle 1 Day 1 and the subject is on anti-coagulation treatment.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: Palleon Clinical

Phone: 857-285-5900

Email: clinical@palleonpharma.com

LOCATION