Study of TRX-920 for Patients With Advanced Solid Tumors

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

This is the first study in which the study drug TRX-920 Oral Gel is being given to humans. However, as a metabolite of Irinotecan, SN38 has proved its effectiveness in the treatment of colorectal and pancreatic cancer. TRX-920 also showed its effect of anti-tumor in various cancer cell lines and animal models. The purposes of this study are to find the highest dose of the study drug that can be given without causing significant side effects, the side effect of the study drug, the concentration of the study drug in the blood, and the effect on your specific cancer. The clinical study will be conducted in Taiwan. The drug used in this study is an investigational product (TRX-920 Oral Gel) which is provided free of charge by TaiRx, Inc. (a pharmaceutical company in Taiwan, and is the sponsor of this study), and is a potential oral anti-cancer therapy for patients suffering from various cancers. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06143774
Study type	Interventional
Source	TaiRx, Inc.
Contact	Yen-Ling Chen, Ph.D.
Phone	+886226535007
Email	yenlingchen@trx.com.tw
Status	Recruiting
Phase	Phase 1
Start date	October 31, 2023
Completion date	January 31, 2026

View Details

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