Studieoverzicht

Study name: 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). (M24SIL)

Histology	NSCLC
Tumor stage	Stage IV
Host / recruiting sites	Antoni van Leeuwenhoek
Enrollment	Recruiting
Therapy line	Later line (≥2L)
Design	open-label, First-In-Human (FIH) Phase I/II, trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), preliminary antitumor activity and efficacy of STX-241, a selective 4 th generation EGFR tyrosine kinase inhibitor (TKI).
Intervention	STX-241 is a fourth generation EGFR TKI, targeting EGFR exon 20 C797S mutation.
Key outcome parameters	Characterize the safety and tolerability of STX-241. To determine the range of doses for Part 2, the optimal biologically active dose (OBD) and the maximum tolerated dose (MTD), of STX-241.
Key inclusion criteria	-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. -Progression after a 3rd generation EGFR TKI-based therapy (monotherapy or in combination) received at any prior line of treatment. -Presence of C797X and absence of T790M mutations documented locally as part of clinical practice on a sample (blood or tissue) collected after progression to a 3rd generation EGFR TKI treatment.
Key exclusion criteria	-Uncontrolled CNS metastases or spinal cord compression that is associated with progressive neurological symptoms or require increasing doses of corticosteroids to control the CNS disease. -Impaired cardiovascular function or clinically significant cardiovascular disease (either active or within 6 months prior to signing main informed consent).
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