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PD-1 Inhibitor

E-602 + Cemiplimab for Cancer (GLIMMER-01 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Palleon Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 months
Awards & highlights

GLIMMER-01 Trial Summary

This trial is testing a new drug, E-602, to see if it is safe and effective when used alone or with another drug, pembrolizumab.

Who is the study for?
This trial is for adults with certain advanced cancers (melanoma, ovarian, NSCLC, colorectal, pancreatic, breast, gastric/EGJ, head and neck or urothelial) that didn't respond to previous treatments. Participants must have a good performance status (able to carry out daily activities), measurable disease by RECIST v1.1 criteria and adequate organ function. Those who've had recent surgery or other treatments are excluded.Check my eligibility
What is being tested?
The GLIMMER-01 study tests E-602 alone and combined with cemiplimab in patients with various advanced cancers. It's an early-phase trial designed to find the right dose and see how well these drugs work together.See study design
What are the potential side effects?
Potential side effects include immune system reactions that could affect organs like the lungs or liver; infusion-related reactions; fatigue; skin issues; hormonal imbalances; digestive problems such as nausea or diarrhea; increased risk of infections.

GLIMMER-01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced cancer and previous treatments didn’t work.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have cancer and it didn't respond to previous immunotherapy treatments.

GLIMMER-01 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-Limiting Toxicities (Phase 1)
Duration of Response (Phase 2)
Incidence of AEs and SAEs (Phase 1)
+3 more
Secondary outcome measures
Duration of Response (Phase 1)
Incidence of AEs and SAEs (Phase 2)
Noncompartmental PK Parameters of E-602 (Phase 1)
+6 more

GLIMMER-01 Trial Design

4Treatment groups
Experimental Treatment
Group I: Expansion - MonotherapyExperimental Treatment1 Intervention
Subjects will receive E-602 as monotherapy at the recommended Phase 2 dose determined in Phase 1.
Group II: Expansion - CombinationExperimental Treatment2 Interventions
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.
Group III: Dose Escalation - MonotherapyExperimental Treatment1 Intervention
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.
Group IV: Dose Escalation - CombinationExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1340

Find a Location

Who is running the clinical trial?

Palleon Pharmaceuticals, Inc.Lead Sponsor

Media Library

Cemiplimab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05259696 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Dose Escalation - Monotherapy, Dose Escalation - Combination, Expansion - Monotherapy, Expansion - Combination
Non-Small Cell Lung Cancer Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT05259696 — Phase 1 & 2
Cemiplimab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05259696 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are subjects being actively sought for this experiment?

"That is correct, the information on clinicaltrials.gov supports that this trial is still open and recruiting patients. The posting date was February 11th, 2022 with the most recent edit on September 20th of the same year. They are looking to enroll 267 individuals total at 8 different locations."

Answered by AI

Are there other facilities in this state that are also testing this new treatment?

"Enrolling patients can be found at 8 locations for this clinical trial, which include Roswell Park Comprehensive Cancer Center in Buffalo, Stanford Health Care in Stanford, Providence Cancer Institute in Portland, and 5 other centres."

Answered by AI

What are we trying to learn from this clinical trial?

"The primary outcome of this study, which will be assessed over a 15-month time frame, is Objective Response Rate (Phase 2). Secondary outcomes include Noncompartmental PK Parameters of E-602 (Phase 1), defined as Area under the plasma concentration-time curve (AUC); Subjects with Antidrug Antibodies (Phase 1), defined as Number and percentage of subjects who develop detectable antidrug antibodies; and Objective Response Rate (Phase 1), defined as Objective response rate of confirmed complete response and partial response using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Immunotherapy Response"

Answered by AI

How many individuals are participating in this experiment?

"In order to carry out this study, 267 individuals that match the necessary inclusion criteria are required. These participants will be recruited from different locations by Palleon Pharmaceuticals, Inc., including Roswell Park Comprehensive Cancer Center in Buffalo, New york and Stanford Health Care in Stanford, Oregon."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Stanford Health Care
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
Glycan Mediated Immune Regulation With a Bi-Sialidase Fusion Protein (GLIMMER-01)
2022. "Glycan Mediated Immune Regulation With a Bi-Sialidase Fusion Protein (GLIMMER-01)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05259696.
All > Colorectal Cancer San Diego > Colon Cancer
~91 spots leftby Jun 2025
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