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)
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- STATUS
- Recruiting
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- End date
- Jun 11, 2025
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- participants needed
- 267
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- sponsor
- Palleon Pharmaceuticals, Inc.
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 Identifier | NCT05259696 |
| Sponsor | Palleon Pharmaceuticals, Inc. |
| Last Modified on | 11 October 2022 |
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