Study design
tumor, unresectable melanoma
TUMOR, SOLID TUMORS
We conducted a first-in-human, phase 1, multicenter, open-label study of tovorafenib in patients with relapsed or refractory advanced solid tumors. The study included a dose escalation phase and a dose expansion phase, with the latter including molecularly defined cohorts of patients with locally advanced, metastatic, and/or unresectable melanoma. The primary objectives were to evaluate the safety and tolerability of tovorafenib administered either Q2D or QW, and to determine the MTD and recommended phase 2 dose (RP2D) on these schedules. Secondary objectives were to evaluate the preliminary antitumor activity and pharmacokinetics (PK) of tovorafenib and to assess the effect of tovorafenib on pharmacodynamic markers in paired tumor biopsies.The protocol was approved by the institutional review boards or independent ethics committees of all participating centers. The study was conducted in accordance with the protocol, Declaration of Helsinki, International Council on Harmonisation Good Clinical Practice guidelines, and applicable regulatory requirements. Written informed consent was obtained from all patients or their guardian/legal representative before study participation.