RecruitingPhase 1Phase 2NCT06567015

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

Phase I/II First-In-Human Open-label Trial to Assess Safety and Efficacy of STX-241 in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Resistant to EGFR Tyrosine Kinase Inhibitors (TKIs).


Sponsor

Pierre Fabre Medicament

Enrollment

171 participants

Start Date

Sep 17, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing STX-241 — a new targeted drug — in patients with advanced non-small cell lung cancer (NSCLC) whose tumors have an EGFR mutation and have developed a specific resistance mutation (C797X) after treatment with third-generation EGFR-blocking drugs. This resistance mutation is a common reason why these lung cancers eventually stop responding to targeted therapy. **You may be eligible if...** - You are 18 or older with confirmed advanced NSCLC (stage IIIB/C or IV) with an EGFR exon 19 deletion or L858R mutation - Your cancer has progressed on a third-generation EGFR inhibitor (like osimertinib) - A blood or tissue test after progression shows the C797X resistance mutation, and does NOT show T790M - You have measurable disease on imaging - You are in good general health (ECOG 0–1) - Your heart, blood, liver, and kidney function are adequate **You may NOT be eligible if...** - Your tumor does not carry the C797X resistance mutation - You are pregnant or breastfeeding - You have serious heart rhythm problems or poor heart function - You have active, uncontrolled infections or autoimmune disease - You have brain metastases that are not stable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSTX-241

Film-coated tablet Route of administration: Oral


Locations(16)

Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium)

Nashville, Tennessee, United States

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

Houston, Texas, United States

Shanghai East Hospital, Tongji University

Shanghai, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Centre Léon Bérard

Lyon, France

CHU Hôpital de la Timone

Marseille, France

Institut de Cancérologie de l'Ouest (ICO) - René Gauducheau

Saint-Herblain, France

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, France

Gustave Roussy

Villejuif, France

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Netherlands Cancer Institute

Amsterdam, Netherlands

Vall d'Hebron Institut d'Oncologia

Barcelona, Spain

Hospital Universitario La Paz

Madrid, Spain

Centro Integral Oncológico Clara Campal (CIOCC)

Madrid, Spain

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06567015


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