A Phase I, Open-label, Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TRX-920 Oral Gel (10 mg and 30 mg) in Patients With Advanced Solid Tumors
The study drug TRX-920 Oral Gel contains SN38, an active metabolite of Irinotecan (CPT-11), which is a widely prescribed anti-cancer drug that has been approved in many countries for the treatment of colorectal and pancreatic cancer. TRX-920 is the oral gel formulation that directly contains SN38 instead of Irinotecan. A series of biology and animal studies have demonstrated that the TRX-920 Oral Gel could inhibit tumor growth with fewer side effects compared to Irinotecan.
⁃ Subjects must meet all of the following criteria to be eligible for enrollment in the study:
• Signed and dated informed consent form
• Histologically and cytologically confirmed advanced solid tumor malignancies that are refractory to standard therapy or have no accepted standard therapy.
• Solid tumors that are measurable or evaluable as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Target lesions that have been previously irradiated will not be considered measurable (lesion).
• Female or male, 18 years of age or older.
• ECOG performance status 0 or 1.
• QTcF ≤ 480 ms at screening.