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).
Pierre Fabre Medicament
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 range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. 3. Histological confirmation of locally advanced or metastatic, EGFR-mutant (ex19del or L858R mutations) non-small cell lung cancer (NSCLC) Stage IIIB/C or IV (AJCC 8th edition) not eligible for curative intent surgery or chemoradiation. 4. Part…
Interventions
- DrugSTX-241
Film-coated tablet Route of administration: Oral
Locations (16)
- Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium)Nashville, Tennessee
- Oncology Consultants (OC) - Texas Medical Center - Cancer CenterHouston, Texas
- Shanghai East Hospital, Tongji UniversityShanghai
- Tianjin Medical University Cancer Institute and HospitalTianjin
- Centre Léon BérardLyon
- CHU Hôpital de la TimoneMarseille