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

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06223308` - A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors	Phase 1/Phase 2
Completed	`NCT05508100` - Dose Confirmation and Dose Expansion Phase 1 Study of IO-108 and IO-108 + Anti-PD-1 in Solid Tumors	Phase 1
Not yet recruiting	`NCT05515185` - B7-H3 Targeting CAR-T Cells Therapy for B7-H3 Positive Solid Tumors	Early Phase 1
Recruiting	`NCT05094804` - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents	Phase 1/Phase 2
Completed	`NCT02836600` - A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors	Phase 1
Recruiting	`NCT04890613` - Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation	Phase 1
Recruiting	`NCT04390737` - Evaluate the Safety and Clinical Activity of HH2853	Phase 1/Phase 2
Recruiting	`NCT05981703` - A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors	Phase 1
Recruiting	`NCT06007482` - A Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors	Phase 1
Completed	`NCT04108676` - Effect of Omeprazole on PK of Fluzoparib in Healthy Male Subjects	Phase 1
Recruiting	`NCT05798611` - Study of ART0380 in Patients With Biologically Selected Solid Tumors	Phase 2
Recruiting	`NCT05076396` - PM14 Administered Intravenously to Patients With Advanced Solid Tumors	Phase 1
Recruiting	`NCT06008366` - A Phase 1/2 Study of 7MW3711 in Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT06054932` - Safety, Tolerability, and Immunogenicity of LK101 Alone in Participants With Incurable Solid Tumors	Phase 1
Recruiting	`NCT04825392` - A Phase Ib Study of HX008 in Patients With Advanced Solid Tumors	Phase 1
Active, not recruiting	`NCT04242199` - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors	Phase 1
Not yet recruiting	`NCT06365918` - Study of VG2025 Delivered Intraperitoneally in Patients With Advanced Solid Tumors With Carcinomatosis	Phase 1
Recruiting	`NCT05569057` - A Phase I Trial of SIM1811-03 in Subjects With Advanced Solid Tumors and Cutaneous T-cell Lymphoma	Phase 1
Recruiting	`NCT05461287` - Safety, Tolerability and Pharmacokinetics Study of QLS31904 in Patients With Advanced Solid Tumors	Phase 1
Recruiting	`NCT05443126` - A Study of EP0031 in Patients With Advanced RET-altered Malignancies	Phase 1/Phase 2