Study of TRX-920 for Patients With Advanced Solid Tumors
NCT ID: NCT06143774
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2023-10-31
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TRX-920 Oral Gel
Dose escalation (escalation from 1, 2, 4, 8, 16, 30, 60, 90 mg TRX-920 Oral Gel)
TRX-920 Oral Gel (10 mg and 30 mg)
TRX-920 Oral Gel will be administered orally at a week (BIW) in an 8-week cycle. No food should be taken 2 hours before and 1 hour after taking TRX-920. The dose escalation/de-escalation rules will be based on definitions of dose-limiting toxicity (DLT) and will be monitored during the first treatment cycle (i.e., the first 4 weeks post the first dose).
The starting dose will be 1 mg and the dosing frequency is twice every week (BIW). Subjects will be assigned to a dose level in sequential cohorts based on the order of their enrollment. The dose escalation will follow a 3+3 design and doses escalate from approximately 1 mg BIW, 2 mg BIW, 4 mg BIW, 8 mg BIW, and 16mg BIW and the doses for subsequent cohorts will be determined by Safety Review Committee (SRC). Dose escalation will be stopped till the maximum tolerated dose (MTD) is reached or identified.
Interventions
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TRX-920 Oral Gel (10 mg and 30 mg)
TRX-920 Oral Gel will be administered orally at a week (BIW) in an 8-week cycle. No food should be taken 2 hours before and 1 hour after taking TRX-920. The dose escalation/de-escalation rules will be based on definitions of dose-limiting toxicity (DLT) and will be monitored during the first treatment cycle (i.e., the first 4 weeks post the first dose).
The starting dose will be 1 mg and the dosing frequency is twice every week (BIW). Subjects will be assigned to a dose level in sequential cohorts based on the order of their enrollment. The dose escalation will follow a 3+3 design and doses escalate from approximately 1 mg BIW, 2 mg BIW, 4 mg BIW, 8 mg BIW, and 16mg BIW and the doses for subsequent cohorts will be determined by Safety Review Committee (SRC). Dose escalation will be stopped till the maximum tolerated dose (MTD) is reached or identified.
Eligibility Criteria
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Inclusion Criteria
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
2. Clinically significant comorbidity such as unstable angina, congestive heart failure (NYHA Grade III or IV), uncontrolled hypertension (\>160/100 mmHg despite optimal medical treatment), chronic obstructive pulmonary disease (COPD) with frequent exacerbations, refractory asthma, inflammatory bowel disease or intestinal obstruction.
3. Acute myocardial infraction or cerebrovascular accident (CVA) within 6 months prior the first dose of study drug.
4. Central nervous system (CNS) metastasis or seizure disorder due to underlying malignancy except those who have been treated and have stable CNS metastases or are asymptomatic.
5. AIDS-defining opportunistic infections within the past 12 months.
6. HBV infection (positive HBsAg) except for carrier of inactive HBV as defined by negative HBeAg with normal ALT and HBV DNA \< 2,000 IU/mL or HCV infection (positive anti-HCV antibody) except for those with undetectable HCV RNA.
7. Inadequate bone marrow reserve, hepatic or renal function as defined by any of the following laboratory values:
1. absolute neutrophil count (ANC) \< 1500/µL
2. platelet count \< 90,000/µL
3. hemoglobin \< 9 g/dL
4. total bilirubin \> 1.5\*the upper limit of normal (ULN)
5. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3\*ULN if no hepatic metastases are present; \> 5\*ULN if hepatic metastases are present
6. Non-indexed eGFR \< 60 mL/min (formula in Appendix 4)
8. Toxicities resulting from prior therapy or surgical procedures not yet resolved to ≤ NCI CTCAE v5.0 Grade 1 with the exception of alopecia, skin hyperpigmentation or hypopigmentation or grade 2 toxicity with prior approval of the Medical Monitor.
9. Major surgical procedures (as defined by Investigator) within 4 weeks prior to the first dose of study drug or any ongoing post-operative complications.
10. Receiving any radiotherapy within 3 months
11. Receiving any (investigational or approved) anti-cancer therapy (including chemotherapy or targeted therapy) within 28 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
12. A history of apparent allergic reactions to irinotecan injection (dosed with prior treatment with prophylactic drug)
13. If female, is pregnant or breastfeeding
14. If men or women with childbearing potential, unwilling to use effective contraceptive methods during the study and for at least 3 months (men) or 1 month (women) after the last dose of study drug. Effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization, or a partner who is sterile.
15. Receiving live attenuated vaccine within 28 days prior to the first dose of study drug.
16. Life expectancy \< 3 months.
17. Other prior or ongoing condition(s) that, in the opinion of the investigator, could affect the safety of the subject, compromise the subject's ability to comply with the study requirements or impair the assessment of study results.
18 Years
100 Years
ALL
No
Sponsors
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TaiRx, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Li-Yuan Bai, M.D.
Role: PRINCIPAL_INVESTIGATOR
China Medical University, Taiwan
Locations
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China Medical University Hospital
Taichung, , Taiwan
National Cheng-Kung University Hospital
Tainan, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SNOF-001
Identifier Type: -
Identifier Source: org_study_id