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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05259696
Recruitment Status : Recruiting
First Posted : February 28, 2022
Last Update Posted : February 17, 2023
Sponsor:
Information provided by (Responsible Party):
Palleon Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Oncology Melanoma Ovarian Cancer NSCLC Non Small Cell Lung Cancer Colorectal Cancer Pancreatic Cancer Cancer CRC Colon Cancer Breast Cancer Gastric Cancer EGJ Esophagogastric Junction Cancer Head and Neck Cancer Urothelial Cancer Bladder Cancer Biological: E-602 Biological: Cemiplimab Phase 1 Phase 2

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 camiplimab. 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 273 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
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: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 11, 2022
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
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.

 Biological: E-602
Subjects will receive E-602 (administered weekly, via IV infusion).
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.

 Biological: E-602
Subjects will receive E-602 (administered weekly, via IV infusion).

Biological: Cemiplimab
Subjects will receive cemiplimab (administered once every 3 weeks, via IV infusion).
Other Names:
  • Libtayo
  • REGN2810
Experimental: Expansion - Monotherapy
Subjects will receive E-602 as monotherapy at the recommended Phase 2 dose determined in Phase 1.
 Biological: E-602
Subjects will receive E-602 (administered weekly, via IV infusion).
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.

 Biological: E-602
Subjects will receive E-602 (administered weekly, via IV infusion).

Biological: Cemiplimab
Subjects will receive cemiplimab (administered once every 3 weeks, via IV infusion).
Other Names:
  • Libtayo
  • REGN2810


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of AEs and SAEs (Phase 1) [ Time Frame: 15 Months ]
    Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

  2. Dose-Limiting Toxicities (Phase 1) [ Time Frame: 21 days ]
    Incidence of dose-limiting toxicities (DLTs) within a modified 3+3 trial design

  3. Objective Response Rate (Phase 2) [ Time Frame: 12 Months ]
    Objective response rate of confirmed complete response and partial response

  4. Duration of Response (Phase 2) [ Time Frame: 16 Months ]
    Duration of Response of confirmed complete response or partial response.

  5. Progression Free Survival (Phase 2) [ Time Frame: 15 Months ]
    Time from first study treatment dose until the first date when progressive disease (PD) is objectively documented or death from any cause

  6. Overall Survival (Phase 2) [ Time Frame: 15 Months ]
    Time from first study treatment dose until death


Secondary Outcome Measures :
  1. Noncompartmental PK Parameters of E-602 (Phase 1) [ Time Frame: 12 Months ]
    Maximum plasma concentration (Cmax)

  2. Noncompartmental PK Parameters of E-602 (Phase 1) [ Time Frame: 12 Months ]
    Area under the plasma concentration-time curve (AUC)

  3. Subjects with Antidrug Antibodies (Phase 1) [ Time Frame: 13 Months ]
    Number and percentage of subjects who develop detectable antidrug antibodies

  4. Objective Response Rate (Phase 1) [ Time Frame: 12 Months ]
    Objective response rate of confirmed complete response and partial response using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST).

  5. Duration of Response (Phase 1) [ Time Frame: 16 Months ]
    Duration of Response of confirmed complete response or partial response

  6. Progression Free Survival (Phase 1) [ Time Frame: 15 Months ]
    Time from first dose to first evidence of radiographically detectable disease or death from any cause

  7. Overall Survival (Phase 1) [ Time Frame: 15 Months ]
    Time from first study treatment dose until death

  8. Incidence of AEs and SAEs (Phase 2) [ Time Frame: 15 Months ]
    Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  9. Noncompartmental PK Parameters of E-602 (Phase 2) [ Time Frame: 12 Months ]
    Maximum plasma concentration (Cmax)

  10. Noncompartmental PK Parameters of E-602 (Phase 2) [ Time Frame: 12 Months ]
    Area under the plasma concentration-time curve (AUC)

  11. Subjects with Antidrug Antibodies (Phase 2) [ Time Frame: 13 Months ]
    Number and percentage of subjects who develop detectable antidrug antibodies


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05259696


Contacts
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Contact: Palleon Clinical 857-285-5900 clinical@palleonpharma.com

Locations
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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Xiomara Menendez, RN       Xiomara.Menendez@med.usc.edu   
Principal Investigator: Anthony El-Khoueiry, MD         
Stanford Health Care Recruiting
Stanford, California, United States, 94305
Contact: Debjani Ghoshal    650-725-5903    debjani.ghoshal@stanford.edu   
Principal Investigator: Chris Chen, MD         
United States, Connecticut
Yale University Cancer Center Recruiting
New Haven, Connecticut, United States, 06520
Contact: Adam Blanchard    203-499-9297    adam.blanchard@yale.edu   
Principal Investigator: Mario Sznol, MD         
United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Julie Burns    616-954-5559    Julie.burns@startmidwest.com   
Principal Investigator: Manish Sharma, MD         
United States, New York
Roswell Park Comprehensive Cancer Center Recruiting
Buffalo, New York, United States, 14263
Contact: Paige Burkard    716-845-1127    paige.burkard@roswellpark.org   
Principal Investigator: Igor Puzanov, MD         
Columbia University Recruiting
New York, New York, United States, 10032
Contact    212-342-5162    cancerclinicaltrials@cumc.columbia.edu   
Principal Investigator: Brian Henick, MD         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Margaret Callahan, MD    646-888-5108    callaham@mskcc.org   
Principal Investigator: Margaret Callahan, MD         
United States, Oregon
Providence Cancer Institute Recruiting
Portland, Oregon, United States, 97213
Contact: Providence Cancer Institute    503-215-2614    CanClinRsrchStudies@providence.org   
Principal Investigator: Brendan Curti, MD         
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: University of Pittsburgh Medical Center       IDDCReferrals@upmc.edu   
Principal Investigator: Jason Luke, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Sarah Cannon Research Institute       asksarah@sarahcannon.com   
Principal Investigator: Melissa Johnson, MD         
United States, Texas
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Cynthia DeLeon    210-580-9500    cdeleon@nextoncology.com   
Principal Investigator: Anthony Tolcher, MD         
Sponsors and Collaborators
Palleon Pharmaceuticals, Inc.
More Information
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Responsible Party: Palleon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05259696    
Other Study ID Numbers: PAL-E602-001
First Posted: February 28, 2022    Key Record Dates
Last Update Posted: February 17, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Palleon Pharmaceuticals, Inc.:
Cancer
Bi-Sialidase
Anti-Tumor
E-602
Cemiplimab
Additional relevant MeSH terms:
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Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents