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A Study of NX-019 in Patients with Advanced, Epidermal Growth Factor Receptor (EGFR) Mutant Cancer
NCT05514496 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG NX-019
Study Locations (12)
Other
- Seoul National University Hospital — Seoul
- Severance Hospital — Seoul
- Asan Medical Center — Seoul
- Samsung Medical Center — Seoul
California
- City of Hope Comprehensive Cancer Center - Duarte — Duarte
- City of Hope - Seacliff — Huntington Beach
- City of Hope Orange County Lennar Foundation Cancer Center — Irvine
Minnesota
- HealthPartners Frauenshuh Cancer Center — Saint Louis Park
- HealthPartners Cancer Center at Regions Hospital — Saint Paul
Virginia
- University Of Virginia Comprehensive Cancer Center — Charlottesville
- NEXT Virginia — Fairfax
Taipei
- National Taiwan University Cancer Center — Taipei City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2022-10-05 |
| Est. Completion | 2025-12-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05514496
The ClinicalTrials.gov registry entry for NCT05514496 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 258 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nalo Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with EGFR Mutation-Related Tumors appearing as the primary indexed condition, and to 1 intervention — of which NX-019 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05514496 reports 12 study locations spanning 5 distinct geographic areas — top geographies include Other, California, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05514496 about?
NCT05514496 is a clinical study titled "A Study of NX-019 in Patients with Advanced, Epidermal Growth Factor Receptor (EGFR) Mutant Cancer". 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.
What is the current status of trial NCT05514496?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 258 participants. The study started on 2022-10-05. Estimated completion is 2025-12-01.
What conditions does trial NCT05514496 study?
This clinical trial studies the following conditions: EGFR Mutation-Related Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05514496?
The interventions under investigation include: NX-019 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05514496?
This trial is sponsored by Nalo Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05514496 being conducted?
This trial has 12 study locations across California, Minnesota, Virginia, Taipei. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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