drugset / Trial / NCT06143774
Study of TRX-920 for Patients With Advanced Solid Tumors
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-10-31
- Primary completion
- 2026-12-31
- Completion
- 2027-06-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 7-ethyl-10-hydroxy Camptothecin | Small molecule | 1 mg | Oral |
| Subject | 7-ethyl-10-hydroxy Camptothecin | Small molecule | 2 mg | Oral |
| Subject | 7-ethyl-10-hydroxy Camptothecin | Small molecule | 4 mg | Oral |
| Subject | 7-ethyl-10-hydroxy Camptothecin | Small molecule | 8 mg | Oral |
| Subject | 7-ethyl-10-hydroxy Camptothecin | Small molecule | 16 mg | Oral |
| Subject | 7-ethyl-10-hydroxy Camptothecin | Small molecule | 30 mg | Oral |
| Subject | 7-ethyl-10-hydroxy Camptothecin | Small molecule | 60 mg | Oral |
| Subject | 7-ethyl-10-hydroxy Camptothecin | Small molecule | 90 mg | Oral |