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.
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).
Show all 14Show fewer
- 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.
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Palleon Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
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.
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.
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
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?
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.