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 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.

Trial Details

NCT ID
NCT06567015
Phase
PHASE1 / PHASE2
Sponsor
Pierre Fabre Medicament
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • STX-241
Locations (sample)
  • Nashville, Tennessee, United States|36.16589,-86.78444
  • Houston, Texas, United States|29.76328,-95.36327
  • Shanghai, China|31.22222,121.45806
  • Tianjin, China|39.14222,117.17667
  • Lyon, France|45.74906,4.84789

Key Eligibility Criteria

  • Signed and dated informed consent for participation in the trial obtained according to International Council for Harmonisation of Technical Require…
  • Male or female ≥ 18 years of age at the time of signing informed consent but at least of legal age in their country.
  • Histological confirmation of locally advanced or metastatic, EGFR-mutant (ex19del or L858R mutations) non-small cell lung cancer (NSCLC) Stage IIIB…
  • Part 1 Disease progression on a 3rd generation EGFR TKI-based therapy (monotherapy or in combination) received at any prior line of treatment.

For full eligibility, visit ClinicalTrials.gov.

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