Safety and Tolerability Study for T-1201 Injection 100 mg Kit in Patients With Advanced Solid Tumors

A Phase I, Open-label, Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of T-1201 Injection 100 mg Kit in Patients With Advanced Solid Tumors

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of T-1201 injection in subjects with advanced solid tumors refractory to standard therapy, or for whom no standard therapy is available. The main questions it aims to answer are:

• The Maximum tolerated dose (MTD) of T-1201 on different dosing schedules.
• The Recommended Phase 2 dose (RP2D) of T-1201 on different dosing schedules.

Researchers will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of T-1201.

Participants will:

Received T-1201 either once every 4 (Part A)/2 (Part B)/3 (Part C) weeks, depend on they participate in which parts of study.

Visit the clinic once every 2/3 weeks for checkups and tests

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: T-1201 Injection 100 mg Kit

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: TJ Wu; Phone Number: 163 +886227486200; Email: tj_wu@taivex.com
• Study Contact Backup: Name: Hsiao-Fang Li, Ph.D; Phone Number: 127 +886227486200; Email: hfli@taivex.com

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
    • Contact: Hui-Ching Wang, M.D.; Phone Number: 886975358630
    • Principal Investigator: Hui-Ching Wang, M.D.
  • Tainan, Taiwan
    • Recruiting
    • National Cheng Kung University Hospital
    • Contact: Yu-Min Yeh, M.D.; Phone Number: 4626 88662353535; Email: i5485111@gmail.com
    • Principal Investigator: Yu-Min Yeh, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for enrollment in the study:

1. Signed and dated informed consent form.
2. Histologically and cytologically confirmed advanced 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, 20 years of age or older.
5. ECOG performance status 0 or 1.
6. QTcF ≤ 470 ms at screening.

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

1. 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.
2. Acute myocardial infarction or cerebrovascular accident (CVA) within 6 months prior the first dose of study drug.
3. 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.
4. AIDS-defining opportunistic infections within the past 12 months.
5. 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.

6. 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 < 100 x 10^9 /µL
   3. hemoglobin < 9 g/dL
   4. total bilirubin > 1.5 x the upper limit of normal (ULN)
   5. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x ULN if no hepatic metastases are present; > 5 x ULN if hepatic metastases are present
   6. Estimated (Cockroft-Gault formula) creatinine clearance (CrCl) < 60 mL/min CrCl = [(140 - age (year)) x weight (kg)] / (serum creatinine x 72) (x 0.85 for females)
7. 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.
8. Major surgical procedures (as defined by Investigator) within 4 weeks prior to the first dose of study drug or any ongoing post-operative complications.
9. 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.
10. A history of apparent allergic reactions to irinotecan, Tween 80 (dosed with prior treatment with prophylactic drug), and/or ethanol.
11. If female, is pregnant or breastfeeding.
12. 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.
13. Receiving live attenuated vaccine within 28 days prior to the first dose of study drug.
14. Life expectancy < 3 months
15. Other prior or ongoing condition(s) that, in Investigator's opinion, 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T-1201 Injection 100 mg Kit; T-1201 Injection 100 mg Kit will be administered via intravenous infusion once every 4 weeks (Part A), 2 weeks (Part B) or 3 weeks (Part C). T-1201 Injection 100 mg Kit is required to be reconstituted with its specific Injection Diluent supplied in the kit, then further diluted with 5% Dextrose solution prior to the intravenous infusion in patients.	Drug: T-1201 Injection 100 mg Kit; T-1201 Injection 100 mg Kit contains lyophilized powder with a sterile aqueous solution formulated for intravenous administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum tolerated dose (MTD)	MTD is highest dose level in which 6 patients have been treated with at most 1 experiencing dose limiting toxicity (DLT).	First treatment cycle (i.e., the first 28 days post the first dose)
Recommended Phase 2 dose (RP2D) dose (RP2D)	To determine the recommended Phase 2 dose (RP2D)	First treatment cycle (i.e., the first 28 days post the first dose)
Frequency, type, severity and relationship to study drug of adverse events (AEs)	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	At least 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic profiles: Cmax of T-1201 and its metabolite(s) [0060 and SN-38]	Maximum plasma concentration (Cmax ) of T-1201, 0060, and SN-38 from plasma concentration-time profiles.	340 hours
Pharmacokinetic profiles: Tmax of T-1201 and its metabolite(s) [0060 and SN-38]	Time to reach maximum concentration (Tmax ) of T-1201, 0060, and SN-38 from plasma concentration-time profiles.	340 hours
Pharmacokinetic profiles: MRT of T-1201 and its metabolite(s) [0060 and SN-38]	Mean residence time (MRT) of T-1201, 0060, and SN-38 from plasma concentration-time profiles.	340 hours
Pharmacokinetic profiles: AUC of T-1201 and its metabolite(s) [0060 and SN-38]	The area under the plasma concentration-time curve (AUC) of T-1201, 0060, and SN-38 from plasma concentration-time profiles.	340 hours
Pharmacokinetic profiles: T1/2 of T-1201 and its metabolite(s) [0060 and SN-38]	Terminal half-life (T1/2 ) of T-1201, 0060, and SN-38 from plasma concentration-time profiles.	340 hours
Assess preliminary anti-tumor activity: ORR of T-1201 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1	Objective response rate (ORR)	At least 56 days
Assess preliminary anti-tumor activity: CBR of T-1201 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1	Clinical benefit rate (CBR)	At least 56 days
Assess preliminary anti-tumor activity: DOR of T-1201 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1	Duration of response (DOR)	At least 56 days
Assess preliminary anti-tumor activity of T-1201 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1	Time to tumor progression per RECIST v1.1	At least 56 days

Collaborators and Investigators

• Sponsor: Taivex Therapeutics Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: TAI-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No