Loading clinical trials...

A Study of NX-019 in Patients with Advanced, Epidermal Growth Factor Receptor (EGFR) Mutant Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

A Study of NX-019 in Patients with Advanced, Epidermal Growth Factor Receptor (EGFR) Mutant Cancer

A First-in-Human, Open-Label, Dose Escalation and Expansion Study of Orally Administered NX-019 in Patients with Advanced, EGFR Mutant Cancer

NCT05514496•Nalo Therapeutics Inc.

View on ClinicalTrials.gov

Summary

This is a 2-part, first-in-human, open-label study to determine the safety and tolerability of NX-019 and preliminary efficacy in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutant cancer.

Detailed Description

Part 1: The primary objective of Part 1 of this study is to evaluate the safety and tolerability of NX-019 and to determine the maximum tolerated dose (MTD)/Recommended Expansion Dose(s) (REDs). Part 2: The primary objective of Part 2 of this study is to confirm the safety and tolerability of NX-019 at the REDs and, for each expansion cohort, the preliminary evidence of efficacy as measured by objective response rate (ORR).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed, locally advanced, or metastatic EGFR-mutant cancer and has progressed on or are intolerant to all standard therapy.
•Patients with non-small cell lung cancer (NSCLC) harboring a mutation that is sensitive to osimertinib must have received osimertinib prior to enrollment.
•Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (evaluable disease acceptable for dose escalation part of study).
•≥18 years of age (or age of consent in in accordance with local law).
•Life expectancy ≥3 months.
•Adequate organ and bone marrow function.
•All patients will have a baseline magnetic resonance imaging (MRI) of the brain.
•Resolution of any clinically significant toxic effects of prior therapy to Grade 0 or 1 according to the National Cancer Institute CTCAE v5.0 (exception of alopecia and Grade 2 peripheral neuropathy).
•Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
•Willingness of men and women of reproductive potential to observe conventional and effective birth control methods with failure rates of \<1% for the duration of treatment and for 6 months following the last dose of study treatment.
+8 more criteria

Exclusion Criteria

•Patients who meet any of the following criteria will be excluded from participation in the study:
•Known C797X EGFR mutations or 1 or more known secondary drivers of disease.
•Disease requiring immediate palliative treatment with surgery or radiation therapy.
•Requirement for greater than 4 mg/day of dexamethasone (or equivalent) for management of CNS metastases.
•Received systemic anticancer chemotherapy, targeted agents, antibody therapy for cancer, immunotherapy for cancer, hormonal therapy or an investigational agent within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study drug treatment.
•Major surgery within 3 weeks prior to start of study drug treatment.
•Radiation therapy within 4 weeks prior to start of study drug treatment.
•Severe or unstable cardiac conditions within 6 months prior to starting study drug treatment.
•Severe or unstable medical condition including uncontrolled diabetes or unstable psychiatric condition.
•Dependent on contact lenses (unable to wear eyeglasses) and unable to comply with ophthalmic guidance.
+10 more criteria

Locations (12)

City of Hope Comprehensive Cancer Center - Duarte

Duarte, California, United States

City of Hope - Seacliff

Huntington Beach, California, United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States

HealthPartners Frauenshuh Cancer Center

Saint Louis Park, Minnesota, United States

HealthPartners Cancer Center at Regions Hospital

Saint Paul, Minnesota, United States

University Of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, United States

NEXT Virginia

Fairfax, Virginia, United States

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Key Dates

Start Date

October 5, 2022

Primary Completion Date

June 1, 2025

Completion Date

December 1, 2025

Last Updated

March 11, 2025

Enrollment

258

ESTIMATED participants

Conditions

EGFR Mutation-Related Tumors

Interventions

NX-019

DRUG