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Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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).

NCT06567015•Pierre Fabre Medicament

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed and dated informed consent for participation in the trial obtained according to International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP), and national/local regulations.
•2. Male or female ≥ 18 years of age at the time of signing informed consent.

Exclusion Criteria

•4. Part 1\&2 Disease progression on a 3rd generation EGFR TKI-based therapy (monotherapy or in combination) received at any prior line of treatment.
•5. Tumor mutation profile:
•• Part 1 (backfilling component) and Part 2: Presence of C797X and absence of T790M mutations documented locally (as part of clinical practice) on a sample (blood or tissue) collected after progression on treatment with 3rd generation EGFR TKI.
•6. Part 1 (Backfilling component), Part 2: At least one measurable target lesion according to RECIST v1.1.
•7. Eastern cooperative oncology group (ECOG) performance status 0-1.
•8. Adequate organ function as defined below:
•* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
•* Platelets ≥ 75 x 10\^9/L
•* Hemoglobin ≥ 90 g/L.
•* Serum total bilirubin ≤ 1.5 x ULN or ≤ 3.0 × ULN for participants with documented Gilbert's syndrome.
+48 more criteria

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

Key Dates

Start Date

September 17, 2024

Primary Completion Date

November 20, 2027

Completion Date

July 1, 2030

Last Updated

September 17, 2025

Enrollment

171

ESTIMATED participants

Conditions

Non-small Cell Lung Cancer (NSCLC)

Interventions

STX-241

DRUG

Contacts

Claire A Fabre, MD

CONTACT

+33 6 42 04 84 76 claire.fabre@pierre-fabre.com

Christine Petilaire Bellet

CONTACT

STX241_medical.team@pierre-fabre.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

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