Actively Recruiting
Study of TRX-920 for Patients With Advanced Solid Tumors
Led by TaiRx, Inc. · Updated on 2026-04-13
30
Participants Needed
3
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of TRX-920 for Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Histologically and cytologically confirmed advanced solid tumor malignancies refractory to standard therapy or with no accepted standard therapy
- Solid tumors measurable or evaluable by RECIST v1.1, excluding previously irradiated target lesions
- Female or male, 18 years of age or older
- ECOG performance status of 0 or 1
- QTcF less than or equal to 480 ms at screening
You will not qualify if you...
- Patients with homozygous or compound heterozygous genotypes for UGT1A1*28 and *6 alleles (e.g., *28/*28, *6/*6, *6/*28)
- Significant comorbidities such as unstable angina, congestive heart failure (NYHA Grade III or IV), uncontrolled hypertension (>160/100 mmHg despite treatment), COPD with frequent exacerbations, refractory asthma, inflammatory bowel disease, or intestinal obstruction
- Acute myocardial infarction or cerebrovascular accident within 6 months prior to first dose
- Central nervous system metastasis or seizure disorder due to malignancy unless treated and stable or asymptomatic
- AIDS-defining opportunistic infections within past 12 months
- HBV infection (positive HBsAg) except inactive carrier status or HCV infection except undetectable RNA
- Inadequate bone marrow, liver, or kidney function by specified lab values
- Unresolved toxicities from prior therapy above Grade 1 except alopecia or skin pigmentation or Grade 2 with approval
- Major surgery within 4 weeks before first dose or ongoing post-operative complications
- Radiotherapy within 3 months before first dose
- Anti-cancer therapy within 28 days or 5 half-lives before first dose
- History of allergic reactions to irinotecan injection
- Pregnant or breastfeeding females
- Men or women of childbearing potential unwilling to use effective contraception during and after study
- Live attenuated vaccine within 28 days before first dose
- Life expectancy less than 3 months
- Other conditions that may affect safety or study compliance as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
China Medical University Hospital
Taichung, Taiwan
Actively Recruiting
2
National Cheng-Kung University Hospital
Tainan, Taiwan
Actively Recruiting
3
Taipei Medical University Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
Y
Yen-Ling Chen, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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