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)

locally advanced or metastatic non-small cell lung cancer (NSCLC) resistant to EGFR tyrosine kinase inhibitors (TKIs)

Part 1: Safety: Incidence and severity of TEAEs/SAEs including changes in physical examination, vital signs, laboratory values, LVEFs and ECGs, according to NCI-CTCAE v5.0 criteria., Part 1: Tolerability: TEAEs/SAEs leading to STX-241 dose reductions, interruptions or discontinuations., Part 1: OBD: Incidence of DLTs during Cycle 1, PK exposure, tumor shrinkage, TEAEs/SAEs ≥ Grade 2. Type, frequency, and severity of TEAEs/SAEs according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria., Part 1: MTD: Incidence of Dose-Limiting Toxicities (DLTs) during Cycle 1 (i.e. the first 28 days of treatment per dose level)., Part 2: Overall safety, PK exposure, PD, confirmed ORR (cORR)by IR, Part 2: Safety: incidence and severity of TEAEs/SAEs including changes in laboratory values, physical examination, vital signs, LVEFs and ECGs according to NCI-CTCAE v5.0 criteria, Part 2: Tolerability: STX-241 dose reductions, interruptions or discontinuations.

Part 1: PK exposure parameters (e.g. Cmax, Tmax, AUC0-tau, AUC0-t, AUC0-∞, t½, λz, CL/F, Vz/F, Rac for Cmax and AUC, and Ctrough)., Part 1: cORR, DCR, TTR and DOR by Investigator Review (IR) in accordance to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)., Part 2: DCR, TTR, DOR, and PFS by RECIST v1.1 by IR., Part 2: Overall Survival (OS)., Part 2: PK exposure parameters (e.g. Cmax, Tmax, AUC0-tau, AUC0-t, AUC0-∞, t½, λz, CL/F, Vz/F, Rac for Cmax and AUC, and Ctrough).

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