OncologyPhase 1/2GLIMMER-01NCT05259696

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

A Phase 1/2 study testing E-602 and Cemiplimab in people with Oncology and Melanoma, run by Palleon Pharmaceuticals, Inc. at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Oncology, Melanoma, Ovarian Cancer
What is being tested?: E-602 and Cemiplimab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 13 sitesUnited States
Study dates: 11 Feb 2022to 24 Oct 2024
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
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

Who cannot join

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).

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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.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
Virginia Cancer Specialists
Fairfax, Virginia, 22031
START Midwest
Grand Rapids, Michigan, 49546
UC San Diego Moores Cancer Center
La Jolla, California, 92093
University of Southern California
Los Angeles, California, 90033
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Yale University Cancer Center
New Haven, Connecticut, 06520
Columbia University
New York, New York, 10032
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Providence Cancer Institute
Portland, Oregon, 97213
NEXT Oncology
San Antonio, Texas, 78229
Stanford Health Care
Stanford, California, 94305

Other trials in United States

About this study

Official title: A Phase 1/2, Open-Label, Single-Arm, Dose-Escalation and Dose-Expansion Study of the Safety, Tolerability, Pharmacokinetic, and Antitumor Activity of E-602 as a Single Agent and in Combination With Cemiplimab in Patients With Advanced Cancers

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.

Read the 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.

Conditions: Oncology, Melanoma, Ovarian Cancer, NSCLC, Non Small Cell Lung Cancer, Colorectal Cancer
Being tested: E-602, Cemiplimab
Keywords: Cancer, Bi-Sialidase, Anti-Tumor, E-602, Cemiplimab
Medical subject headings: Neoplasms, Melanoma, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Pancreatic Neoplasms, Colonic Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

E-602Biological
Subjects will receive E-602 (administered weekly, via IV infusion).
CemiplimabBiological
Also called Libtayo, REGN2810
Subjects will receive cemiplimab (administered once every 3 weeks, via IV infusion).

Study groups in NCT05259696
Study group	Role	What they receive
Dose Escalation - Monotherapy	Experimental	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. Receives: Biological: E-602
Dose Escalation - Combination	Experimental	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. Receives: Biological: E-602; Biological: Cemiplimab
Expansion - Monotherapy	Experimental	Subjects will receive E-602 as monotherapy at the recommended Phase 2 dose determined in Phase 1. Receives: Biological: E-602
Expansion - Combination	Experimental	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. Receives: Biological: E-602; Biological: Cemiplimab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experienced AEs or SAEs
Number of participants who experienced an adverse events (AEs) or a serious adverse event (SAE)
Measured: 15 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Feb 202224 Oct 2024

First posted28 Feb 2022
Study start11 Feb 2022
Primary completion24 Oct 2024
Study completion24 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OncologyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
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: None (open label)
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05259696
Sponsor's protocol ID: PAL-E602-001
Acronym: GLIMMER-01
Status last verified: Aug 2025
First submitted: 11 Feb 2022
Last updated: 20 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2, Open-Label, Single-Arm, Dose-Escalation and Dose-Expansion Study of the Safety, Tolerability, Pharmacokinetic, and Antitumor Activity of E-602 as a Single Agent and in Combination With Cemiplimab in Patients With Advanced Cancers
ClinicalTrials.gov ID: NCT05259696
Acronym / sponsor ID: GLIMMER-01 / PAL-E602-001
Conditions: Oncology, Melanoma, Ovarian Cancer, NSCLC, Non Small Cell Lung Cancer, Colorectal Cancer
Keywords: Cancer, Bi-Sialidase, Anti-Tumor, E-602, Cemiplimab
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: Palleon Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 11 Feb 2022 (actual)
Primary completion: 24 Oct 2024 (actual)
Study completion: 24 Oct 2024 (actual)
First posted: 28 Feb 2022 (actual)
Results: Posted 20 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4
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.

Arm	Type	Receives
Dose Escalation - Monotherapy	Experimental	Biological: E-602Subjects 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.
Dose Escalation - Combination	Experimental	Biological: E-602, Biological: CemiplimabSubjects 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.
Expansion - Monotherapy	Experimental	Biological: E-602Subjects will receive E-602 as monotherapy at the recommended Phase 2 dose determined in Phase 1.
Expansion - Combination	Experimental	Biological: E-602, Biological: CemiplimabSubjects 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.
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 criteria (14 listed)

For cohorts receiving E-602 and cemiplimab combination therapy:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
E-602Subjects will receive E-602 (administered weekly, via IV infusion).	Biological	Dose Escalation - Combination, Dose Escalation - Monotherapy, Expansion - Combination, Expansion - Monotherapy
CemiplimabAlso: Libtayo, REGN2810Subjects will receive cemiplimab (administered once every 3 weeks, via IV infusion).	Biological	Dose Escalation - Combination, Expansion - Combination

Primary outcome

Number of Participants Who Experienced AEs or SAEs
Time frame: 15 Months
Number of participants who experienced an adverse events (AEs) or a serious adverse event (SAE)

Results and safety

Results posted to the registry on 20 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
E-602 1 mg/kg	5	5
E-602 3 mg/kg	4	4
E-602 10 mg/kg	9	9
E-602 20 mg/kg	15	15
E-602 30 mg/kg	15	15
E-602 20 mg/kg in Combination With Cemiplimab	21	21

Primary outcome: Number of Participants Who Experienced AEs or SAEs

Time frame: 15 Months. Count of participants. Unit: Participants

Measure	E-602 1 mg/kg n = 5	E-602 3 mg/kg n = 4	E-602 10 mg/kg n = 9	E-602 20 mg/kg n = 15	E-602 30 mg/kg n = 15	E-602 20 mg/kg in Combination With Cemiplimab n = 21
Participants with any Treatment Emergent AE	5	4	8	15	15	20
Participants with any Serious AE	3	1	1	6	5	5

Adverse events

Time frame: Adverse events were collected through the treatment period, up to 12 months, and up to 3 months after treatment discontinuation.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
E-602 1 mg/kg	3 of 5 (60%)	5 of 5 (100%)	5 of 5
E-602 3 mg/kg	1 of 4 (25%)	4 of 4 (100%)	1 of 4
E-602 10 mg/kg	1 of 9 (11.1%)	8 of 9 (88.9%)	7 of 9
E-602 20 mg/kg	6 of 15 (40%)	15 of 15 (100%)	9 of 15
E-602 30 mg/kg	5 of 15 (33.3%)	15 of 15 (100%)	6 of 15
E-602 20 mg/kg in Combination With Cemiplimab	5 of 21 (23.8%)	20 of 21 (95.2%)	5 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing E-602 and Cemiplimab in people with Oncology and Melanoma, run by Palleon Pharmaceuticals, Inc. at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced AEs or SAEs (time frame: 15 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05259696.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.