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

NCT04866641 | Recruiting Phase 1 FDA Drug

• 1 other identifier: TAI-201
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Pharmacokinetic profiles: Cmax of T-1201 and its metabolite(s) [0060 and SN-38]

  340 hours

• Pharmacokinetic profiles: Tmax of T-1201 and its metabolite(s) [0060 and SN-38]

  340 hours

• Pharmacokinetic profiles: MRT of T-1201 and its metabolite(s) [0060 and SN-38]

  340 hours

• Pharmacokinetic profiles: AUC of T-1201 and its metabolite(s) [0060 and SN-38]

  340 hours

• Pharmacokinetic profiles: T1/2 of T-1201 and its metabolite(s) [0060 and SN-38]

  340 hours

Study Arms (1)

T-1201 Injection 100 mg Kit

EXPERIMENTAL

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

Interventions

T-1201 Injection 100 mg Kit DRUG

T-1201 Injection 100 mg Kit contains lyophilized powder with a sterile aqueous solution formulated for intravenous administration.

T-1201 Injection 100 mg Kit

Eligibility Criteria

• Age: 20 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 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, 20 years of age or older.
• ECOG performance status 0 or 1.
• QTcF ≤ 470 ms at screening.

You may not qualify if:

• Subjects presenting with any of the following will not be included in the study:
• 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 infarction 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 \< 100 x 10\^9 /µL
• hemoglobin \< 9 g/dL
• total bilirubin \> 1.5 x the upper limit of normal (ULN)
• aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x ULN if no hepatic metastases are present; \> 5 x ULN if hepatic metastases are present
• 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)
• 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.
• 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

• Taivex Therapeutics Corporation: lead

Study Sites (2)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

MeSH Terms

Interventions

Receptor Protein-Tyrosine Kinases

Intervention Hierarchy (Ancestors)

Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cell Surface; Membrane Proteins

Central Study Contacts

Hsiao-Fang Li, Ph.D

CONTACT

+886227486200; hfli@taivex.com

TJ Wu

CONTACT

+886227486200; tj_wu@taivex.com

Study Design

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

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 30, 2021
• Study Start: June 24, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

TW (2)