Actively Recruiting
Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs
Led by Pierre Fabre Medicament · Updated on 2025-09-17
171
Participants Needed
16
Research Sites
301 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent according to regulations.
- Male or female aged 18 years or older.
- Histologically confirmed locally advanced or metastatic EGFR-mutant NSCLC (Stage IIIB/C or IV) not eligible for curative surgery or chemoradiation.
- Disease progression on third generation EGFR TKI therapy.
- Presence of C797X mutation and absence of T790M mutation after progression on third generation EGFR TKI.
- At least one measurable target lesion per RECIST v1.1.
- ECOG performance status 0-1.
- Adequate organ function including neutrophils, platelets, hemoglobin, bilirubin, liver enzymes, and kidney filtration rate.
- Adequate cardiac function including QTcF limits, left ventricular ejection fraction ≥50%, and controlled blood pressure.
- Female participants of childbearing potential must have negative pregnancy tests before dosing and agree to use effective contraception during and after the trial.
- Male participants with partners of childbearing potential must agree to use barrier contraception and avoid sperm donation during and after the trial.
You will not qualify if you...
- Eligible for other targeted therapies such as ALK, BRAF, MET, NTRK, or ROS1 inhibitors.
- Rapidly progressive disease suitable for platinum-based chemotherapy.
- Unable to swallow or digest tablets due to gastrointestinal conditions.
- History of other primary malignancies except certain treated cancers with no residual disease.
- Spinal cord compression or symptomatic CNS metastases requiring increasing corticosteroids.
- History of allergies to STX-241 or similar drugs.
- Active infections including uncontrolled HIV, hepatitis B or C, tuberculosis, or recent infections requiring treatment.
- Positive or suspected COVID-19 infection near the start of treatment.
- Significant cardiovascular disease or recent cardiac events.
- Uncontrolled illnesses or psychiatric/social conditions limiting compliance.
- Past or active interstitial lung disease or severe skin conditions like Stevens-Johnson Syndrome.
- Breastfeeding women.
- Recent prior anticancer therapies or live vaccines.
- Toxicities from prior therapy exceeding specified grades.
- Recent major surgery without adequate healing.
- Use of prohibited medications or herbal remedies affecting drug metabolism.
- Participation in another investigational drug trial recently.
- Any condition judged by the investigator to compromise participant safety or study assessments.
- Employment or family relation to study staff.
AI-Screening
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Trial Site Locations
Total: 16 locations
1
Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium)
Nashville, Tennessee, United States, 37203
Actively Recruiting
2
Oncology Consultants (OC) - Texas Medical Center - Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
3
Shanghai East Hospital, Tongji University
Shanghai, China, 200120
Actively Recruiting
4
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China, 300060
Actively Recruiting
5
Centre Léon Bérard
Lyon, France, 69008
Actively Recruiting
6
CHU Hôpital de la Timone
Marseille, France, 13385
Actively Recruiting
7
Institut de Cancérologie de l'Ouest (ICO) - René Gauducheau
Saint-Herblain, France, 44800
Actively Recruiting
8
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France, 31059
Actively Recruiting
9
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
10
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 1307
Actively Recruiting
11
Netherlands Cancer Institute
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
12
Vall d'Hebron Institut d'Oncologia
Barcelona, Spain, 8035
Actively Recruiting
13
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
14
Centro Integral Oncológico Clara Campal (CIOCC)
Madrid, Spain, 28050
Actively Recruiting
15
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
16
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
Research Team
C
Claire A Fabre, MD
CONTACT
C
Christine Petilaire Bellet
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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