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

ClinicalTrials.gov ID: NCT05514496

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05514496
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: Nalo Therapeutics Inc.; Industry
Enrollment: 258 participants

Conditions and interventions

Conditions

EGFR Mutation-Related Tumors

Interventions

NX-019 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 5, 2022 (Actual)
Primary completion: Jun 1, 2025 (Estimated)
Completion: Dec 1, 2025 (Estimated)
Last update posted: Mar 11, 2025

2022 – 2025

United States locations

U.S. sites: 7
U.S. states: 3
U.S. cities: 7

Facility	City	State	ZIP	Site status
City of Hope Comprehensive Cancer Center - Duarte	Duarte	California	91010	—
City of Hope - Seacliff	Huntington Beach	California	92648	—
City of Hope Orange County Lennar Foundation Cancer Center	Irvine	California	92618	—
HealthPartners Frauenshuh Cancer Center	Saint Louis Park	Minnesota	55426	—
HealthPartners Cancer Center at Regions Hospital	Saint Paul	Minnesota	55101	—
University Of Virginia Comprehensive Cancer Center	Charlottesville	Virginia	22903	—
NEXT Virginia	Fairfax	Virginia	22031	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05514496, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 11, 2025 · Synced Nov 13, 2026