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NCT05259696 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2025-08-20

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants Who Experienced AEs or SAEs

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Subjects 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.
    intervention Names
    1. Biological: E-602
    label
    Dose Escalation - Monotherapy
    type
    EXPERIMENTAL
  2. description
    Subjects 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.
    intervention Names
    1. Biological: E-602
    2. Biological: Cemiplimab
    label
    Dose Escalation - Combination
    type
    EXPERIMENTAL
  3. description
    Subjects will receive E-602 as monotherapy at the recommended Phase 2 dose determined in Phase 1.
    intervention Names
    1. Biological: E-602
    label
    Expansion - Monotherapy
    type
    EXPERIMENTAL
  4. description
    Subjects 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.
    intervention Names
    1. Biological: E-602
    2. Biological: Cemiplimab
    label
    Expansion - Combination
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Dose Escalation - Combination
    2. Dose Escalation - Monotherapy
    3. Expansion - Combination
    4. Expansion - Monotherapy
    description
    Subjects will receive E-602 (administered weekly, via IV infusion).
    name
    E-602
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Dose Escalation - Combination
    2. Expansion - Combination
    description
    Subjects will receive cemiplimab (administered once every 3 weeks, via IV infusion).
    name
    Cemiplimab
    other Names
    1. Libtayo
    2. REGN2810
    type
    BIOLOGICAL
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
intervention Model Description
Phase 1: The study uses a modified 3+3 design with 5 planned dose levels of E-602 as monotherapy and 2 planned dose levels of E-602 in combination with cemiplimab. Phase 2: Consists of dose-expansion and will use the recommended Phase 2 dose level for E-602 as monotherapy and in combination with cemiplimab.
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
69
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Number of participants who experienced an adverse events (AEs) or a serious adverse event (SAE)
    measure
    Number of Participants Who Experienced AEs or SAEs
    time Frame
    15 Months
Full study description
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 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.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice