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 (GLIMMER-01)

  • STATUS
    Recruiting
  • End date
    Jun 11, 2025
  • participants needed
    267
  • sponsor
    Palleon Pharmaceuticals, Inc.
Updated on 11 October 2022
renal function
cancer
breast cancer
bone marrow procedure
pembrolizumab
primary cancer
pancreatic cancers
kidney function test
cancer of the ovary

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.

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.

Details
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
Treatment Pembrolizumab, E-602
Clinical Study IdentifierNCT05259696
SponsorPalleon Pharmaceuticals, Inc.
Last Modified on11 October 2022

Eligibility

Yes No Not Sure

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
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

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
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