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PD-1 Inhibitor

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

Phase 1 & 2

Waitlist Available

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

Must not have

Subject is taking the equivalent of >10 mg/day oral prednisone or on systemic immunosuppressive therapy

Untreated brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have brain metastases that have not been treated.

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I have a cancer that has gotten worse or needed treatment in the last 3 years.

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I haven't had recent surgery, new treatments, infections, non-healing wounds, or uncontrolled bleeding.

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I have been diagnosed with age-related macular degeneration.

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I have received a transplant from another person.

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I have been treated with idelalisib before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-Limiting Toxicities (Phase 1)

Duration of Response (Phase 2)

Incidence of AEs and SAEs (Phase 1)

+3 more

Secondary study objectives

Duration of Response (Phase 1)

Incidence of AEs and SAEs (Phase 2)

Noncompartmental PK Parameters of E-602 (Phase 1)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1470

0 / 10Eligibility criteria met