drugset / Trial / NCT06567015
Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs
NaSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2024-09-17
- Primary completion
- 2027-11-20
- Completion
- 2030-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | STX-241 | Small molecule | 10 mg | Oral |
| Subject | STX-241 | Small molecule | 20 mg | Oral |
| Subject | STX-241 | Small molecule | 40 mg | Oral |
| Subject | STX-241 | Small molecule | 80 mg | Oral |
| Subject | STX-241 | Small molecule | 120 mg | Oral |
| Subject | STX-241 | Small molecule | 180 mg | Oral |