E-602 + Cemiplimab for Cancer

(GLIMMER-01 Trial)

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

69 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+