Safety and Tolerability Study for T-1101 (Tosylate) Capsules to Treat Advanced Refractory Solid Tumors

NCT04685473 | Active Not Recruiting Phase 1

• 1 other identifier: TAI-003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

T-1101 (Tosylate) is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by Taivex Therapeutics Corp. T-1101 (Tosylate) is a potent anti-cancer agent in numerous human cancer cell lines. In addition, oral administration of T-1101 (Tosylate) showed tumor growth inhibition in different mouse xenograft models of human cancers. In this study, safety, tolerability and pharmacokinetic (PK) of T-1101 (Tosylate) capsules will be evaluated and also the recommended dose and regimen(s) to initiate Phase 2 will be determined.

Conditions

Advanced Refractory Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of T-1101 (Tosylate) in Participants with Advanced Cancers Refractory to Standard Therapy

  MTD is highest dose level of 30% target toxicity rate and the MTD will be determined based on the occurrence of the dose-limiting toxicity (DLT) assessed using toxicity data during Cycle 1 (the first 28 days). When following toxicity events occur within the first 28-day cycle, these toxicity will be defined as DLT. 1. Hematological toxicities : prolonged grade 4 neutropenia for \>7 days, grade 3 febrile neutropenia (an ANC \< 1000/mm3 with a single temperature of \> 38.3°C or a sustained temperature of \> 38°C for more than 1 hour), grade 4 febrile neutropenia (febrile neutropenia with life-threatening consequences; urgent intervention indicated), Grade 3 or 4 neutropenia with IV treatment for infection and grade 3 thrombocytopenia with bleeding or grade 4 lasting 7 days. 2. Non-hematological toxicities: grade 3 or 4 toxicities, Nausea and vomiting or diarrhea must persist at grade 3 or 4 despite maximal medical therapy.

  The first 28-day cycle

Secondary Outcomes (5)

• Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) to the time of the last measurable concentration and to infinity of T-1101 (Tosylate)

  Selected time points during first 28-day cycle

• Pharmacokinetics: Time to maximum plasma concentration (Tmax) and terminal half-life (T½) of T-1101 (Tosylate)

  Selected time points during first 28-day cycle

• Pharmacokinetics: Oral plasma clearance (CL/F) of T-1101 (Tosylate)

  Selected time points during first 28-day cycle

• Pharmacokinetics: Apparent volume of distribution (Vd/F) of T-1101 (Tosylate)

  Selected time points during first 28-day cycle

• Clinical Tumor Response of T-1101 (Tosylate) in Participants with Advanced Cancers

  Up to 2 years

Study Arms (1)

T-1101 (Tosylate)

EXPERIMENTAL

Drug: T-1101 (Tosylate)

Interventions

T-1101 (Tosylate) DRUG

T-1101 (Tosylate) Capsule

T-1101 (Tosylate)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study
• Histologically and cytologically confirmed advanced malignancies that are refractory to standard treatments
• 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) unless increase in size is observed following completion of radiation therapy
• Have a life expectancy of ≥3 months in the investigator's opinion
• Females or males ≥ 20 years old
• ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
• Recovered from prior treatment-related toxicity to at least grade 1 with exception of alopecia
• Adequate organ function as defined by the following criteria:
• Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
• Total serum bilirubin ≤ 1.5 x ULN
• Absolute neutrophil count (ANC) ≥ 1500/μL
• Platelets ≥ 100,000/μL
• Hemoglobin ≤ 9.0 g/dL
• Creatinine clearance (CrCl) ≥ 50 mL/min CrCl = \[(140 - age (year)) x weight (kg)\] / (serum creatinine x 72) (x 0.85 for females)
• Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.

You may not qualify if:

• Major surgery within 4 weeks prior to starting T-1101 (Tosylate).
• Subjects received any of the following anti-cancer therapies:
• Anti-cancer radiation therapy within 2 weeks prior to starting T-1101 (Tosylate).
• Palliative radiation (≤ 10 fractions) within 48 hours prior to the screening
• Any systemic cytotoxic chemotherapy within 2 weeks or 5 half-lives (whichever is greater) prior to starting T-1101 (Tosylate)
• Any target therapy within 2 weeks prior to starting T-1101 (Tosylate)
• Any interventional treatments in another clinical trial within 2 weeks or 5-half-lives (whichever is greater) prior to starting T-1101 (Tosylate)
• Documented or suspected brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
• Any of the following within 6 months of starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack
• Ongoing cardiac dysrhythmias of ≥ NCI CTCAE v5.0 grade 2, or atrial fibrillation of any grade
• Hypertension that cannot be controlled by medications (\> 160/100 mm-Hg despite optimal medical therapy).
• Known human immunodeficiency virus (HIV) infection
• A positive test for hepatitis B (HBsAg) or hepatitis C (anti-HCV (hepatitis C virus) antibody), unless the HBV (hepatitis B virus) DNA level and/or HCV RNA level is below the limit of detection.
• Men and women of childbearing potential who are unwilling to use highly effective contraceptive methods during the study period.
• Highly effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.

Sponsors & Collaborators

• Taivex Therapeutics Corporation: lead

Study Sites (2)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Study Design

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

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 28, 2020
• Study Start: January 7, 2021
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)