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ZN-e4 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Phase 1 | EXPERIMENTAL | Up to 9 sequential dose escalation cohorts to determine maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified. |
| Phase 2 | EXPERIMENTAL | MTD/RP2D in subjects: Cohort 1: with T790M mutation in epidermal growth factor receptor (EGFR) gene, and are osimertinib naïve. Cohort 2: EGFRm amenable to EGFR inhibitor therapy (eg, exon 19 del, L858R) and who have never been treated with EGFRis. |
| Name | Type | Description |
|---|---|---|
| ZN-e4 | DRUG | Oral dose, tablet, daily dosing |
INCLUSION CRITERIA * Age ≥ 18 years * Histologically or cytologically confirmed metastatic or advanced inoperable diagnosis of NSCLC * Documented radiographic progression on the last treatment administered prior to enrolling in the study. * Phase 1 only: Confirmation that the tumor harbors an EGFR ...
ZN-e4 is an investigational small molecule being studied for non-small cell lung cancer, specifically in patients whose tumors carry an epidermal growth factor receptor mutation. It is being developed by Zentalis Pharmaceuticals and has been evaluated in a Phase 1 study in this biomarker-selected lung cancer population.
ZN-e4 is being developed by Zentalis Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ZNTL. The company sponsored the clinical study of ZN-e4 in epidermal growth factor receptor mutated non-small cell lung cancer.
ZN-e4 is in Phase 1 clinical development. Its single registered trial, NCT03446417, was a Phase 1 study that has been completed. ZN-e4 is investigational and has not been approved by the FDA for any indication.
ZN-e4 has been studied in one registered clinical trial, NCT03446417, titled A Study of ZN-e4 in Subjects With Epidermal Growth Factor Receptor Mutated Non-Small Cell Lung Cancer. The Phase 1 trial enrolled 34 participants across the United States and Bosnia and Herzegovina and is now completed.
No. ZN-e4 is an investigational drug in Phase 1 clinical development and has not been approved by the FDA. Its only registered study, NCT03446417, has been completed, and the drug remains under clinical evaluation for epidermal growth factor receptor mutated non-small cell lung cancer.