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Clinical Trials associated with STI-7349An Open-label, Dose Escalation and Dose Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of STI-7349 in Subjects With Advanced Solid Tumors
This is a first-in-human, Phase Ⅰ, open-label, 2-period dose escalation and expansion study of STI-7349 administered intravenously to subjects with advanced solid tumors:
Period I is divided into two parts: Dose escalation for STI-7349 alone (1A) and dose expansion for STI-7349 alone (1B). In Part 1A, a rapid titration approach and traditional 3 + 3 trial design will be used to assess the safety, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), PK/biomarker profile, and to determine the recommended Phase 2 dose (RP2D) of STI-7349 alone; in Part 1B, an expansion study of STI-7349 alone will be conducted in target tumor types that may potentially benefit to assess the safety and preliminary efficacy of STI-7349 alone.
Period Ⅱ is divided into two parts: Dose escalation for STI-7349 in combination with Pembrolizumab (2A) and dose expansion for STI-7349 in combination with Pembrolizumab (2B). In Part 2A, a dose escalation study of STI-7349 in combination with Pembrolizumab is planned to be conducted using ½ RP2D of STI-7349 alone as the starting dose, which will use a traditional 3 + 3 trial design to assess the safety, DLTs, MTD, PK/biomarker profile of STI-7349 in combination with Pembrolizumab, and to determine the RP2D of STI-7349 in combination with Pembrolizumab; in Part 2B, an expansion study of STI-7349 in combination with Pembrolizumab or add standard treatment on the basis of STI-7349 combined with pembrolizumab will be conducted in target tumor types that may potentially benefit to assess the safety and preliminary efficacy of the combination.
100 Clinical Results associated with STI-7349
100 Translational Medicine associated with STI-7349
100 Patents (Medical) associated with STI-7349
100 Deals associated with STI-7349