E-602 + Cemiplimab for Cancer

(GLIMMER-01 Trial)

No longer recruiting at 13 trial locations

Overseen By Palleon Clinical

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Palleon Pharmaceuticals, Inc.

Must not be taking: Idelalisib, Prednisone, Immunosuppressants, others

Disqualifiers: Autoimmune disease, AMD, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for certain advanced or treatment-resistant cancers, such as melanoma, ovarian, or lung cancer. It tests the safety and effectiveness of E-602 (an experimental treatment), both alone and with another drug called cemiplimab (also known as Libtayo, an immunotherapy). People with specific cancers that did not respond to previous treatments might be suitable candidates. The trial aims to assess how well these drugs work together and determine the best dose for patients. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, if you are taking more than 10 mg/day of oral prednisone or other systemic immunosuppressive therapy, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that E-602 is generally safe. In earlier studies, E-602 had lasting effects on immune cells for up to seven days after administration. It was also well-tolerated when used alone. When combined with cemiplimab, E-602 remained safe.

Cemiplimab is already approved for treating some types of cancer, indicating its well-established safety. It is used for non-small cell lung cancer and has been tested with other treatments.

Overall, research suggests that both E-602 and cemiplimab are generally safe for patients. However, discussing any possible side effects with the trial team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of E-602 and cemiplimab for cancer treatment because these therapies have the potential to enhance the immune system's ability to target and destroy cancer cells. Unlike other treatments, which might rely solely on inhibiting cancer growth, E-602 works by modifying the tumor microenvironment, potentially making cancer cells more susceptible to immune attack. Cemiplimab, an immune checkpoint inhibitor, helps unmask cancer cells to the immune system, and when combined with E-602, it could lead to a more robust anti-cancer response. This innovative approach could offer a new avenue for patients who have limited options with existing treatments like chemotherapy or other immunotherapies.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that E-602, one of the treatments in this trial, has potential in treating various types of cancer when used alone. Early studies found that E-602 is safe and can affect tumors at certain doses. In this trial, some participants will receive E-602 as monotherapy, while others will receive a combination of E-602 with another drug, cemiplimab. This combination appears to alter tumors in a way that might help the immune system fight cancer more effectively. Cemiplimab alone has successfully helped people live longer with certain cancers, such as skin cancer. This suggests that both E-602 on its own and in combination with cemiplimab could be beneficial in cancer treatment. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have advanced cancer and previous treatments didn’t work.

My blood, kidney, and liver tests are within normal ranges.

Subject has disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1

Exclusion Criteria

I have had serious lung issues in the past or currently that needed treatment.

I am on more than 10 mg/day of oral prednisone or similar medication.

I haven't had a vaccine or radiotherapy in the last 14 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Dose Escalation

Dose escalation cohorts of E-602 as a monotherapy and in combination with cemiplimab to identify the maximum tolerated dose

12 months

Phase 2: Dose Expansion

Dose-expansion disease cohorts in subjects with advanced tumors to evaluate safety and efficacy

16 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab
• E-602
• Pembrolizumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Expansion - Monotherapy Experimental Treatment 1 Intervention

Subjects will receive E-602 as monotherapy at the recommended Phase 2 dose determined in Phase 1.

Group II: Expansion - Combination Experimental Treatment 2 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 - Monotherapy Experimental Treatment 1 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 - Combination Experimental Treatment 2 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.

Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:

Approved in European Union as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)
• Non-small cell lung cancer (NSCLC)

Approved in United States as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)
• Basal cell carcinoma (BCC)
• Non-small cell lung cancer (NSCLC)

Approved in Canada as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)
• Non-small cell lung cancer (NSCLC)

Approved in Brazil as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)

Who Is Running the Clinical Trial?

Palleon Pharmaceuticals, Inc.

Lead Sponsor

Trials

1

Recruited

70+

Citations

1. jitc.bmj.com jitc.bmj.com/content/12/Suppl_2/A862

758 GLIMMER-01: phase 1/2 trial of a first-in-class bi- ... In Phase 1, E-602 monotherapy was tolerable at doses up to 30 mg/kg and achieved dose-dependent pharmacodynamic (PD) effects for up to 48 hours ...

2. palleonpharma.com palleonpharma.com/wp-content/uploads/ePoster-SITC-2024-Palleon-E-602-Combo-Final-QR.pdf

Phase 1/2 Trial of a First-in-class Bi-sialidase (E-602) in ... Here we present the safety, efficacy and tumor PD effects of E-602 combination with Cemiplimab (anti-PD-1) in PD-(L)1-resistance cancer patients.

3. ecancer.org ecancer.org/en/video/11241-initial-results-from-a-phase-1-dose-escalation-trial-of-e-602-shows-efficacy-in-solid-tumours

Initial results from a phase 1 dose escalation trial of E-602 ... The drug is given on a weekly basis and essentially what we were able to show in this study was that the drug is safe. We look forward to the ...

4. aacrjournals.org aacrjournals.org/cancerres/article/83/8_Supplement/CT034/725204/Abstract-CT034-GLIMMER-01-initial-results-from-a

Abstract CT034: GLIMMER-01: initial results from a phase 1 ... A Phase 1/2 first-in-human dose escalation study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of E-602 in ...

5. onclive.com onclive.com/view/dr-luke-on-early-data-from-the-glimmer-01-trial-of-e-602-in-advanced-solid-tumors

Dr Luke on Initial Data From the GLIMMER-01 Trial of E- ... The first-in-human GLIMMER-01 study was designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of E-602 in ...

6. aacrjournals.org aacrjournals.org/cancerres/article/82/12_Supplement/LB203/704688/Abstract-LB203-Assessment-of-the-safety

Abstract LB203: Assessment of the safety, pharmacokinetics ... ... E-602's safety profile. E-602 has demonstrated sustained PD effects of immune cell desialylation up to seven days postdose and a wide safety ...

7. palleonpharma.com palleonpharma.com/press-releases/palleon-presents-preclinical-data-on-lead-program-e-602-and-novel-bifunctional-pd-l1-targeted-sialidase/

Palleon Presents Preclinical Data on Lead Program E-602 ... E-602 exhibits sustained, dose-dependent effects on desialylation of immune cells and a wide safety margin –. – Bifunctional PD-L1-Targeted ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05259696

Study Details | NCT05259696 | Glycan Mediated Immune ... This study is being conducted to evaluate the safety, tolerability, PK, pharmacodynamics, and antitumor activity of E-602 in subjects with advanced cancers.

9. palleonpharma.com palleonpharma.com/wp-content/uploads/2022-E-602-Poster-AACR-Final.pdf

E-602, a Sialoglycan Degrader, in Non-Human Primates To support clinical development, we conducted a Good Laboratory Practice (GLP) one- month repeat-dose toxicity study to evaluate E-602's pharmacokinetic (PK) ...