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

Part of paid clinical trials in La Jolla, California.

Sponsor
Palleon Pharmaceuticals, Inc.
Study ID
NCT05259696
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 11, 2022
Status verified
Aug 2025
Primary completion
Oct 24, 2024
Completion
Oct 24, 2024

Study Design

Enrollment
69 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation - Monotherapy
    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.
  • Experimental: Dose Escalation - Combination
    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.
  • Experimental: Expansion - Monotherapy
    Subjects will receive E-602 as monotherapy at the recommended Phase 2 dose determined in Phase 1.
  • Experimental: Expansion - Combination
    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.

Primary Outcome Measure

Number of Participants Who Experienced AEs or SAEs [ Time Frame: 15 Months ]

Locations (13)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
University of Southern CaliforniaLos AngelesCalifornia90033-
Stanford Health CareStanfordCalifornia94305-
Yale University Cancer CenterNew HavenConnecticut06520-
Massachusetts General HospitalBostonMassachusetts02114-
START MidwestGrand RapidsMichigan49546-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-
Columbia UniversityNew YorkNew York10032-
Providence Cancer InstitutePortlandOregon97213-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
Sarah Cannon Research InstituteNashvilleTennessee37203-
NEXT OncologySan AntonioTexas78229-
Virginia Cancer SpecialistsFairfaxVirginia22031-

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