Study of TRX-920 for Patients With Advanced Solid Tumors

NCT06143774 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SNOF-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Advanced Solid Tumor

Keywords

TRX-920 Oral Gel; SN38

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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

  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

  Cycle 1 Day 1 to study completion, an average of 1 year (each cycle is 56 days)

Study Arms (1)

TRX-920 Oral Gel

EXPERIMENTAL

Dose escalation (escalation from 1, 2, 4, 8, 16, 30, 60, 90 mg TRX-920 Oral Gel)

Drug: TRX-920 Oral Gel (10 mg and 30 mg)

Interventions

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.

TRX-920 Oral Gel

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• TaiRx, Inc.: lead

Study Sites (3)

China Medical University Hospital

Taichung, Taiwan

RECRUITING

National Cheng-Kung University Hospital

Tainan, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, Taiwan

RECRUITING

Study Officials

• Li-Yuan Bai, M.D.

  China Medical University, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yen-Ling Chen, Ph.D.

CONTACT

+886226535007; yenlingchen@trx.com.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose-finding Study using 3+3 design.

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 22, 2023
• Study Start: October 31, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 15, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

TW (3)