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NCT06567015 · ClinicalTrials.gov registry record · Phase 1

Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs

A Phase 1 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Pierre Fabre Medicament.

Recruiting
Registry status
Phase 1
Development phase
171
Enrollment target
16
Study locations

NCT06567015 is a Phase 1 study of Non-small Cell Lung Cancer (NSCLC) that is actively recruiting participants, run by Pierre Fabre Medicament. The registered enrollment target is 171 participants, below the 286-participant average among 58 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (40% lower). The trial reports 16 study locations across 3 states.

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The verdict

NCT06567015, a Phase 1 study of Non-small Cell Lung Cancer (NSCLC), is actively recruiting participants, sponsored by Pierre Fabre Medicament.

RECRUITING
Registry status
Phase 1
Development phase
171 participants
Enrollment target
16
Study locations

Study Summary

The goal of this First-In-Human (FIH) Phase I/II trial is to establish the safety profile, determine the Recommended Phase II Dose (RP2D), explore the pharmacokinetic (PK) exposure and pharmacodynamic (PD) properties as well as assess the efficacy of STX-241/PFL-241, a mutant selective Central Nervous System (CNS)-penetrant fourth generation EGFR TKI, in participants with locally advanced or metastatic NSCLC that progressed during or following third generation EGFR TKI such as osimertinib due to C797X double acquired (secondary) mutations.

Conditions Studied

Non-small Cell Lung Cancer (NSCLC)

Interventions

  • DRUG STX-241

Study Locations (16)

Other

  • Shanghai East Hospital, Tongji University - Shanghai
  • Tianjin Medical University Cancer Institute and Hospital - Tianjin
  • Centre Léon Bérard - Lyon
  • CHU Hôpital de la Timone - Marseille
  • Institut de Cancérologie de l'Ouest (ICO) - René Gauducheau - Saint-Herblain
  • Institut Universitaire du Cancer de Toulouse - Oncopole - Toulouse
  • Gustave Roussy - Villejuif
  • Universitätsklinikum Carl Gustav Carus Dresden - Dresden
  • Netherlands Cancer Institute - Amsterdam
  • Vall d'Hebron Institut d'Oncologia - Barcelona
  • Hospital Universitario La Paz - Madrid
  • Centro Integral Oncológico Clara Campal (CIOCC) - Madrid
  • National Taiwan University Hospital - Taipei
  • Taipei Veterans General Hospital - Taipei

Tennessee

  • Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium) - Nashville

Texas

  • Oncology Consultants (OC) - Texas Medical Center - Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 171 participants
Start Date 2024-09-17
Est. Completion 2030-07
Phase Phase 1

Sponsor

Pierre Fabre Medicament

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06567015

The ClinicalTrials.gov registry entry for NCT06567015 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 171 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 286-participant average among 58 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (40% lower). The listed sponsor is Pierre Fabre Medicament, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 1 intervention - of which STX-241 is the first listed.

NCT06567015 reports 16 study locations spanning 3 distinct geographic areas - top geographies include Other, Tennessee, Texas.

Frequently Asked Questions

What is clinical trial NCT06567015 about?

NCT06567015 is a clinical study titled "Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs". The goal of this First-In-Human (FIH) Phase I/II trial is to establish the safety profile, determine the Recommended Phase II Dose (RP2D), explore the pharmacokinetic (PK) exposure and pharmacodynamic (PD) properties as well as assess the efficacy of STX-241/PFL-241, a mutant selective Central Nervo...

What is the current status of trial NCT06567015?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 171 participants. The study started on 2024-09-17. Estimated completion is 2030-07.

What conditions does trial NCT06567015 study?

This clinical trial studies the following conditions: Non-small Cell Lung Cancer (NSCLC).

What interventions are being tested in trial NCT06567015?

The interventions under investigation include: STX-241 (DRUG).

Who is sponsoring clinical trial NCT06567015?

This trial is sponsored by Pierre Fabre Medicament, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06567015 being conducted?

This trial has 16 study locations across Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.