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

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 Pembrolizumab in Patients With Advanced Cancers

INTRODUCTION

  • Org Study ID: PAL-E602-001
  • Secondary ID: N/A
  • NTC ID: NCT05259696
  • Sponsor: Palleon Pharmaceuticals, Inc.

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 pembrolizumab.

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 pembrolizumab. 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 pembrolizumab.

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 pembrolizumab. 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 267 subjects (up to 81 in Phase 1 and up to 186 in Phase 2). Subjects will participate in the study for about 16 months.

  • Overall Status
    Recruiting
  • Start Date
    February 11, 2022
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of AEs and SAEs (Phase 1)

Primary Outcome 1 - Timeframe: 15 Months

Primary Outcome 2 - Measure: Dose-Limiting Toxicities (Phase 1)

Primary Outcome 2 - Timeframe: 21 days

Primary Outcome 3 - Measure: Immune-Related Toxicities (Phase 1)

Primary Outcome 3 - Timeframe: 15 Months

Primary Outcome 4 - Measure: Objective Response Rate (Phase 2)

Primary Outcome 4 - Timeframe: 12 Months

Primary Outcome 5 - Measure: Duration of Response (Phase 2)

Primary Outcome 5 - Timeframe: 16 Months

Primary Outcome 6 - Measure: Progression Free Survival (Phase 2)

Primary Outcome 6 - Timeframe: 15 Months

Primary Outcome 7 - Measure: Overall Survival (Phase 2)

Primary Outcome 7 - Timeframe: 15 Months

CONDITION

  • 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

ELIGIBILITY

Key Inclusion Criteria:
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).
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:
For cohorts receiving E-602 and pembrolizumab combination therapy:
Prior moderate or severe hypersensitivity to pembrolizumab or its formulation

- History of severe autoimmune complications or discontinuation due to toxicity following treatment with an anti-PD-(L)1 pathway therapy.

- Subject has an active autoimmune disease with the exception of auto-immune endocrinopathies that are stable on hormone replacement therapy.

- Subject has a history of colitis.

- 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 pneumonitis or has current non-infectious pneumonitis or interstitial lung disease.

- Untreated brain metastases or another untreated primary malignancy

- 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 857-285-5900

Email: clinical@palleonpharma.com

LOCATION

Facility Status Contact