Safety & Tolerability Study for T-1201 Injection 100 mg Kit in Patients

Status Recruiting

Clinical Trial Summary

This clinical development plan for T-1201 will begin with a first-in-human (FIH), open label, multi-center Phase I dose-escalation to evaluate the safety, tolerability, and human pharmacokinetics of T-1201 and determine the maximum tolerated dose (MTD) levels in patients with advanced solid cancer. The further Phase II study will then be designed based on the safety, pharmacokinetics, and preliminary efficacy results from the FIH Phase I study. The initial part of the Phase I study is a safety, tolerability, and pharmacokinetic phase wherein T-1201 Injection will be intravenous administered to patients with advanced solid cancers. The study will be an open label, multi-center Phase I dose-escalation study. Approximately 30-40 patients will be enrolled for the dose-escalation phase. Actual number of patients will be determined by the number of dose cohorts until maximum tolerated dose (MTD) is reached. The modified accelerated titration design will be used for dose escalation. The initial dose regimen will be 18 mg/m 2 of T-1201 Injection once every 4 weeks in 28-day cycles. Doses will escalate in the following sequence: 18, 36, 71, 119, 178 and 249 mg/m 2 of T-1201 Injection. Dose escalation will cease when 2/3 or 2/6 patients experience a DLT, or a dose of 249 mg/m 2 is reached. A DLT must occur within the first cycle (Cycle 1) to determine dose escalation between cohorts. If 2/3 or 2/6 patients experience DLTs at the initial dose level of 18 mg/m 2 , 2 more dose levels lower than 18 mg/m 2 will be added to the study. No human study has been conducted for product T-1201, the benefits/risks of T-1201 is therefore not available at this stage. Since T-1201 is a prodrug of SN-38 with target delivery design, the benefits/risks ratio of T-1201 would thus be expected to be more favorable than irinotecan product (CAMPTOSAR ® , Pfizer).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04866641
Study type	Interventional
Source	Taivex Therapeutics Corporation
Contact	Hsiao-Fang Li, Ph.D
Phone	+886227486200
Email	hfli@taivex.com
Status	Recruiting
Phase	Phase 1
Start date	June 24, 2021
Completion date	December 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms