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ZN-e4

Phase 1

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Zentalis Pharmaceuticals, Inc.|Last Updated: Jan 25, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

ZN-e4 · 1 trial · 1 indication

Phase 1 1
NCT03446417A Study of ZN-e4 in Subjects With Epidermal Growth Factor Receptor Mutated Non-Small Cell Lung CancerCarcinoma, Non-Small-Cell Lung
COMPLETED34 Analytics
PHASE1COMPLETED
A Study of ZN-e4 in Subjects With Epidermal Growth Factor Receptor Mutated Non-Small Cell Lung Cancer
Carcinoma, Non-Small-Cell LungUnlock trial analytics

Study Endpoints

Primary Endpoints

Observed dose limiting toxicities
1 Cycle (21 days)

Secondary Endpoints

Safety and tolerability as measured by incidence of treatment emergent adverse events
Through study completion, approximately 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1EXPERIMENTALUp to 9 sequential dose escalation cohorts to determine maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified.
Phase 2EXPERIMENTALMTD/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.

Interventions

NameTypeDescription
ZN-e4DRUGOral dose, tablet, daily dosing
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

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 ...

Countries:United StatesBosnia and Herzegovina
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Frequently asked questions about ZN-e4

What is ZN-e4 used for?

ZN-e4 is an investigational small molecule being studied for the treatment of carcinoma, non-small-cell lung cancer. It is being developed by Zentalis Pharmaceuticals, Inc. (ticker: ZNTL) and is currently in Phase 1 clinical development.

What does ZN-e4 target?

ZN-e4 is being studied in patients with epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer, indicating it targets the EGFR pathway. It is a small molecule therapeutic being developed by Zentalis Pharmaceuticals, Inc. for this oncology indication.

Who makes ZN-e4?

ZN-e4 is being developed by Zentalis Pharmaceuticals, Inc., a biopharmaceutical company traded on the stock exchange under the ticker ZNTL. The drug is an investigational small molecule intended for the treatment of non-small cell lung cancer.

What phase is ZN-e4 in?

ZN-e4 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A Phase 1 study of ZN-e4 in subjects with EGFR-mutated non-small cell lung cancer has been completed.

What clinical trials is ZN-e4 in?

ZN-e4 has been studied in one clinical trial, identified as NCT03446417, titled 'A Study of ZN-e4 in Subjects With Epidermal Growth Factor Receptor Mutated Non-Small Cell Lung Cancer'. This Phase 1 trial enrolled 34 participants and has been completed.

Is ZN-e4 the same as any other drug?

ZN-e4 is the investigational name for the drug being developed by Zentalis Pharmaceuticals, Inc. No alternative names for ZN-e4 have been disclosed in the available clinical trial information.