Advanced Solid TumorPhase 1NCT06143774
Study of TRX-920 for Patients With Advanced Solid Tumors
A Phase 1 study testing TRX-920 Oral Gel (10 mg and 30 mg) in people with Advanced Solid Tumor, run by TaiRx, Inc. at 3 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- TRX-920 Oral Gel (10 mg and 30 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesTaiwan
- Study dates
- 31 Oct 2023to 15 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be eligible for enrollment in the study:
- Signed and dated informed consent form
- Histologically and cytologically confirmed advanced solid tumor malignancies that are refractory to standard therapy or have no accepted standard therapy.
- 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).
- Female or male, 18 years of age or older.
- ECOG performance status 0 or 1.
- QTcF ≤ 480 ms at screening.
Who cannot join
- Patients with homozygous or compound heterozygous genotypes for UGT1A1*28 and *6 alleles (e.g., *28/*28, *6/*6, *6/*28).
- 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.
- Acute myocardial infraction or cerebrovascular accident (CVA) within 6 months prior the first dose of study drug.
- 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.
- AIDS-defining opportunistic infections within the past 12 months.
- 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.
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- Inadequate bone marrow reserve, hepatic or renal function as defined by any of the following laboratory values:
- absolute neutrophil count (ANC) < 1500/µL
- platelet count < 90,000/µL
- hemoglobin < 9 g/dL
- total bilirubin > 1.5*the upper limit of normal (ULN)
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3*ULN if no hepatic metastases are present; > 5*ULN if hepatic metastases are present
- Non-indexed eGFR < 60 mL/min (formula in Appendix 4)
- 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.
- Major surgical procedures (as defined by Investigator) within 4 weeks prior to the first dose of study drug or any ongoing post-operative complications.
- Receiving any radiotherapy within 3 months
- 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
- A history of apparent allergic reactions to irinotecan injection (dosed with prior treatment with prophylactic drug)
- If female, is pregnant or breastfeeding
- 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.
- Receiving live attenuated vaccine within 28 days prior to the first dose of study drug.
- Life expectancy < 3 months.
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan3 sites, 3 recruiting
- Recruiting
China Medical University Hospital
Taichung
Li-Yuan Bai, +886975680928, lybai6@gmail.com
- Recruiting
National Cheng-Kung University Hospital
Tainan
Yu-Min Yeh, +886-6-235-3535 ext. 4289, i5485111@gmail.com
- Recruiting
Taipei Medical University Hospital
Taipei
Chao-Hua Chiu, +886970405247, chaohuachiu@gmail.com
About this study
Official title: A Phase I, Open-label, Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TRX-920 Oral Gel (10 mg and 30 mg) in 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. 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.
Read the detailed 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- TRX-920 Oral Gel (10 mg and 30 mg)
- Keywords
- TRX-920 Oral Gel, SN38
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRX-920 Oral Gel (10 mg and 30 mg)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| TRX-920 Oral Gel | Experimental | Dose escalation (escalation from 1, 2, 4, 8, 16, 30, 60, 90 mg TRX-920 Oral Gel) Receives: Drug: TRX-920 Oral Gel (10 mg and 30 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of TRX-920 Oral Gel
The MTD is defined as the highest dose level at which no more than 1 in 6 subjects experiences a DLT. The recommended Phase 2 dose (RP2D) will be determined by Safety Review Committee based on all available PK, safety, and preliminary efficacy data. The RP2D will not exceed the MTD.
Measured: the first 4 weeks post the first dose
Frequency, type, severity and relationship to study drug of adverse events (AEs) of TRX-920 Oral Gel
AEs will be coded by system organ class (SOC) and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) system.
Measured: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days)
Secondary outcomes (9)
Drug exposure and human pharmacokinetics (Cmax) of SN38 derived from plasma concentration-time profiles
The plasma concentrations of SN38 will be analyzed using compartmental or non-compartmental approach to calculate Cmax for individual subjects.
Measured: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days)
Drug exposure and human pharmacokinetics (Tmax) of SN38 derived from plasma concentration-time profiles
The plasma concentrations of SN38 will be analyzed using compartmental or non-compartmental approach to calculate Tmax for individual subjects.
Measured: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days)
Drug exposure and human pharmacokinetics (MRT) of SN38 derived from plasma concentration-time profiles
The plasma concentrations of SN38 will be analyzed using compartmental or non-compartmental approach to calculate MRT for individual subjects.
Measured: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days)
Drug exposure and human pharmacokinetics (AUC) of SN38 derived from plasma concentration-time profiles
The plasma concentrations of SN38 will be analyzed using compartmental or non-compartmental approach to calculate AUC for individual subjects.
Measured: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days)
Drug exposure and human pharmacokinetics (terminal half-life) of SN38 derived from plasma concentration-time profiles
The plasma concentrations of SN38 will be analyzed using compartmental or non-compartmental approach to calculate terminal half-life (T 1/2) for individual subjects.
Measured: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days)
Objective response rate (ORR) per RECIST v1.1
Tumor assessment by computed tomography (CT) or magnetic resonance imaging (MRI) will be performed every 8-week cycle starting from Cycle 2 Day 1. All subjects will attend an End of Treatment (EOT) visit at the time decision is made to discontinue study drug administration.
The Objective response rate (ORR) as per RECIST v1.1 will be calculated in the efficacy population.
Measured: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days)
Disease control rate (DCR) per RECIST v1.1
Tumor assessment by computed tomography (CT) or magnetic resonance imaging (MRI) will be performed every 8-week cycle starting from Cycle 2 Day 1. All subjects will attend an End of Treatment (EOT) visit at the time decision is made to discontinue study drug administration.
The disease control rate (DCR) as per RECIST v1.1 will be calculated in the efficacy population.
Measured: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days)
Duration of response (DOR) per RECIST v1.1
Tumor assessment by computed tomography (CT) or magnetic resonance imaging (MRI) will be performed every 8-week cycle starting from Cycle 2 Day 1. All subjects will attend an End of Treatment (EOT) visit at the time decision is made to discontinue study drug administration.
The duration or response (DOR) as per RECIST v1.1 will be calculated in the efficacy population.
Measured: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days), assessed up to 24 months
Time to tumor progression (TTP) per RECIST v1.1
Tumor assessment by computed tomography (CT) or magnetic resonance imaging (MRI) will be performed every 8-week cycle starting from Cycle 2 Day 1. All subjects will attend an End of Treatment (EOT) visit at the time decision is made to discontinue study drug administration.
The time to tumor progression (TTP) as per RECIST v1.1 will be calculated in the efficacy population.
Measured: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days), assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start31 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dose-finding Study using 3+3 design.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TaiRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li-Yuan Bai, M.D., Principal investigator, China Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143774
- Sponsor's protocol ID
- SNOF-001
- Status last verified
- Apr 2026
- First submitted
- 6 Nov 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TRX-920 Oral Gel (10 mg and 30 mg) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06143774
- Acronym / sponsor ID
- SNOF-001
- Conditions
- Advanced Solid Tumor
- Keywords
- TRX-920 Oral Gel, SN38
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- TaiRx, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose-finding Study using 3+3 design.
| Arm | Type | Receives |
|---|---|---|
| TRX-920 Oral Gel | Experimental | Drug: TRX-920 Oral Gel (10 mg and 30 mg)Dose escalation (escalation from 1, 2, 4, 8, 16, 30, 60, 90 mg TRX-920 Oral Gel) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must meet all of the following criteria to be eligible for enrollment in the study:
- Signed and dated informed consent form
- Histologically and cytologically confirmed advanced solid tumor malignancies that are refractory to standard therapy or have no accepted standard therapy.
- 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).
- Female or male, 18 years of age or older.
Key exclusion criteria (23 listed)
- Patients with homozygous or compound heterozygous genotypes for UGT1A1*28 and *6 alleles (e.g., *28/*28, *6/*6, *6/*28).
- 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.
- Acute myocardial infraction or cerebrovascular accident (CVA) within 6 months prior the first dose of study drug.
- 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.
- AIDS-defining opportunistic infections within the past 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | TRX-920 Oral Gel |
Primary outcome
Maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of TRX-920 Oral Gel
Time frame: the first 4 weeks post the first dose
The MTD is defined as the highest dose level at which no more than 1 in 6 subjects experiences a DLT. The recommended Phase 2 dose (RP2D) will be determined by Safety Review Committee based on all available PK, safety, and preliminary efficacy data. The RP2D will not exceed the MTD.
Frequency, type, severity and relationship to study drug of adverse events (AEs) of TRX-920 Oral Gel
Time frame: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days)
AEs will be coded by system organ class (SOC) and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) system.
9 secondary outcomes
Drug exposure and human pharmacokinetics (Cmax) of SN38 derived from plasma concentration-time profiles
Time frame: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days)
Drug exposure and human pharmacokinetics (Tmax) of SN38 derived from plasma concentration-time profiles
Time frame: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days)
Drug exposure and human pharmacokinetics (MRT) of SN38 derived from plasma concentration-time profiles
Time frame: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days)
Drug exposure and human pharmacokinetics (AUC) of SN38 derived from plasma concentration-time profiles
Time frame: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days)
Drug exposure and human pharmacokinetics (terminal half-life) of SN38 derived from plasma concentration-time profiles
Time frame: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days)
Objective response rate (ORR) per RECIST v1.1
Time frame: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days)
Disease control rate (DCR) per RECIST v1.1
Time frame: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days)
Duration of response (DOR) per RECIST v1.1
Time frame: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days), assessed up to 24 months
Time to tumor progression (TTP) per RECIST v1.1
Time frame: Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days), assessed up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li-Yuan Bai, M.D. principal investigator
China Medical University, Taiwan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRX-920 Oral Gel (10 mg and 30 mg) in people with Advanced Solid Tumor, run by TaiRx, Inc. at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yen-Ling Chen, Ph.D. (+886226535007 ext. 113, yenlingchen@trx.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of TRX-920 Oral Gel (time frame: the first 4 weeks post the first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.