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NCT06046495 · ClinicalTrials.gov registry record · Phase 1

A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer

A Phase 1 study of Non-Small Cell Lung Cancer, sponsored by Avistone Biotechnology Co..

Recruiting
Registry status
Phase 1
Development phase
81
Enrollment target
7
Study locations

NCT06046495 is a Phase 1 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by Avistone Biotechnology Co.. The registered enrollment target is 81 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (88% lower). The trial reports 7 study locations across 6 states.

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The verdict

NCT06046495, a Phase 1 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by Avistone Biotechnology Co..

RECRUITING
Registry status
Phase 1
Development phase
81 participants
Enrollment target
7
Study locations

Study Summary

This is a Phase I, multicenter, open-label, dose escalation and dose expansion study to assess the safety and pharmacokinetic profile of PLB1004, a mono-anilino-pyrimidine compound, given alone in NSCLC patients with EGFR exon 20 insertion mutations，uncommon mutations, classical mutations (Ex19del and L858R), and drug-resistant mutation (T790M). Patients will be enrolled and dosed according to the most current protocol. This study is made of two Parts. Part 1 includes a dose escalation into 7 cohorts and patient allocation to these cohorts will be via slot allocation. Each cohort has a minimum of 3 and a maximum of 6 patients for a total of 21 - 42 patients. The patient population of the dose escalation phase will include patients with advanced NSCLC harboring EGFR classical mutations or Ex20ins mutations, or uncommon mutations. Part 2 includes an expansion phase and the expansion phase will explore one or more dose levels of PLB1004 in NSCLC patients with EGFR Ex20ins mutations, classical mutations, or uncommon mutations.

Conditions Studied

Non-Small Cell Lung Cancer

Interventions

  • DRUG PLB1004

Study Locations (7)

Washington

  • Swedish Health Sciences - Seattle
  • Research Site - Seattle

California

  • University of California-Davis - Sacramento

Kentucky

  • Research Site - Louisville

Nebraska

  • Nebraska Cancer Specialists - Omaha

New York

  • Research Site - New York

Tennessee

  • Sarah Cannon Research Institute - Nashville

Trial Details

FieldValue
Enrollment Target 81 participants
Start Date 2024-07-08
Est. Completion 2028-02-09
Phase Phase 1

Sponsor

Avistone Biotechnology Co.

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06046495

The ClinicalTrials.gov registry entry for NCT06046495 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (88% lower). The listed sponsor is Avistone Biotechnology Co., which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which PLB1004 is the first listed.

NCT06046495 reports 7 study locations spanning 6 distinct geographic areas - top geographies include Washington, California, Kentucky.

Frequently Asked Questions

What is clinical trial NCT06046495 about?

NCT06046495 is a clinical study titled "A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer". This is a Phase I, multicenter, open-label, dose escalation and dose expansion study to assess the safety and pharmacokinetic profile of PLB1004, a mono-anilino-pyrimidine compound, given alone in NSCLC patients with EGFR exon 20 insertion mutations，uncommon mutations, classical mutations (Ex19del a...

What is the current status of trial NCT06046495?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2024-07-08. Estimated completion is 2028-02-09.

What conditions does trial NCT06046495 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.

What interventions are being tested in trial NCT06046495?

The interventions under investigation include: PLB1004 (DRUG).

Who is sponsoring clinical trial NCT06046495?

This trial is sponsored by Avistone Biotechnology Co., which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06046495 being conducted?

This trial has 7 study locations across California, Kentucky, Nebraska, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.