Study of TRX-920 for Patients With Advanced Solid Tumors

"TRX-920 Oral Gel will be administered orally at a week (BIW) in an 8-week cycle. No food should be taken 2 hours before and 1 hour after taking TRX-920. The dose escalation/de-escalation rules will be based on definitions of dose-limiting toxicity (DLT) and will be monitored during the first treatment cycle (i.e., the first 4 weeks post the first dose).~The starting dose will be 1 mg and the dosing frequency is twice every week (BIW). Subjects will be assigned to a dose level in sequential cohorts based on the order of their enrollment. The dose escalation will follow a 3+3 design and doses escalate from approximately 1 mg BIW, 2 mg BIW, 4 mg BIW, 8 mg BIW, and 16mg BIW and the doses for subsequent cohorts will be determined by Safety Review Committee (SRC). Dose escalation will be stopped till the maximum tolerated dose (MTD) is reached or identified."