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A Study of ZN-e4 in Subjects With Epidermal Growth Factor Receptor Mutated Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03446417
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Zeno Pharmaceuticals, Inc.

Brief Summary:
This is a Phase 1/2, open-label, multicenter, sequential dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-e4 administered orally in subjects with advanced non-small cell lung cancer (NSCLC) with activating EGFR mutations who have progressed while on treatment with an EGFR tyrosine kinase inhibitor (TKI) agent (other lines of treatment are allowed, except for other epidermal growth factor receptor inhibitors [EGFRis]) for Phase 1; and for Phase 2, subjects who have T790M+ and are osimertinib naïve (Cohort 1), and also those who have not been treated with an EGFR Inhibitor (EGFRi) (Cohort2).

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: ZN-e4 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of ZN-e4 (KP-673) in Patients With Advanced Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor (EGFR) Mutations
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : June 20, 2022
Estimated Study Completion Date : December 20, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Urogastrone

Arm Intervention/treatment
Experimental: Phase 1
Up to 9 sequential dose escalation cohorts to determine maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified.
Drug: ZN-e4
Oral dose, tablet, daily dosing

Experimental: Phase 2

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.

Drug: ZN-e4
Oral dose, tablet, daily dosing




Primary Outcome Measures :
  1. Observed dose limiting toxicities [ Time Frame: 1 Cycle (21 days) ]

Secondary Outcome Measures :
  1. Safety and tolerability as measured by incidence of treatment emergent adverse events [ Time Frame: Through study completion, approximately 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 mutation known to be associated with aberrations that are amenable to EGFRi therapy including but not limited to: G719X, exon 19 deletion, exon 21 L858R, and L861Q. OR − Must have experienced clinical benefit from an EGFRi,
  • All acute toxic effects of any prior antitumor therapy resolved to Grade ≤1 or baseline before the start of study drug dosing (with the exception of alopecia [any grade permitted] and neurotoxicity [Grade 1 or 2 permitted]).
  • Measurable disease meeting the criteria specified by RECIST v1.1
  • Phase 2, Cohort 1 only: Subjects must have confirmation of tumor T790M mutation status (confirmed positive) and are osimertinib naïve
  • Phase 2, Cohort 2 only: EGFR aberrations that are amenable to EGFRi therapy, including but not limited to: G719X, exon 19 deletion, exon 21 L858R, and L861Q, and be EGFRi naïve

EXCLUSION CRITERIA

  • Subjects who have received only neoadjuvant or adjuvant therapy for NSCLC.
  • Phase 1 only: Treatment with an EGFRi within 7 days or 5 half-lives of the first dose of study treatment, whichever is shorter.
  • Phase 1 only: Cytotoxic chemotherapy, investigational agents, or any anticancer therapy for the treatment of advanced NSCLC (other than EGFRi) within 21 days of the first dose of study treatment.
  • Prior treatment with immunotherapy within 3 months prior to the first dose of study treatment.
  • Radiotherapy within 28 days of first dose of study treatment; subjects given palliative radiotherapy to peripheral sites (e.g., bone metastases) may enter the study before 28 days have elapsed provided the radiated sites do not contain lesions which may be used to evaluate response, and must have recovered from any acute, reversible effects.
  • Known or suspected central nervous system (CNS) metastases or leptomeningeal disease (Phase 1 only). Subjects with previously treated brain or CNS metastases are eligible provided that the subject has recovered from any acute effects of radiotherapy, does not have brain metastasis related symptoms, is not requiring systemic steroids for at least 2 weeks prior to study drug administration, and any whole brain radiation therapy was completed at least 4 weeks prior to study drug administration, or any stereotactic radiosurgery (SRS) was completed at least 2 weeks prior to study drug administration.
  • Prior allogeneic bone marrow transplantation.
  • History of a concurrent or second malignancy except for: adequately treated local basal cell or squamous cell carcinoma of the skin; cervical carcinoma in situ; superficial bladder cancer; breast carcinoma in situ; adequately treated Stage 1 or 2 cancer currently in complete remission; any other cancer that has been in complete remission for ≥5 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446417


Contacts
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Contact: Zeno Pharmaceuticals 858-263-4333 info@zenopharma.com

Locations
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United States, California
Site 2 Recruiting
Duarte, California, United States, 91010
United States, Michigan
Site 5 Recruiting
Detroit, Michigan, United States, 48201
United States, New York
Site 1 Recruiting
East Setauket, New York, United States, 11733
United States, North Carolina
Site 6 Recruiting
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
Site 3 Recruiting
Gettysburg, Pennsylvania, United States, 17325
Sponsors and Collaborators
Zeno Pharmaceuticals, Inc.
Investigators
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Study Director: Zeno Pharmaceuticals Zeno Pharmaceuticals
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Responsible Party: Zeno Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03446417    
Other Study ID Numbers: ZN-e4-001
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases