Study of TRX-920 for 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.
| Condition(s) | Advanced Solid Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for enrollment in the study: 1. Signed and dated informed consent form 2. Histologically and cytologically confirmed advanced solid tumor malignancies that are refractory to standard therapy or have no accepted standard therapy. 3. 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). 4. Female or male, 18 years of age or older. 5. ECOG performance status 0 or 1. 6. QTcF ≤ 480 ms at screening. Exclusion Criteria: 1. Patients with homozygous or compound heterozygous genotypes for UGT1A1\*28 and \*6 alleles (e.g., \*28/\*28, \*6/\*6, \*6/\*28). 2. Clinicall |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Lead sponsor | TaiRx, Inc. |
| Locations | Taichung, Taiwan; Tainan, Taiwan; Taipei, Taiwan |
| Start date | 2023-10-31 |
| NCT ID | NCT06143774 |
| Official listing | https://clinicaltrials.gov/study/NCT06143774 |