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Safety and Tolerability Study for T-1301 Capsules to Treat Advanced Solid Tumors

NCT05156203 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-11-12

No results posted yet for this study

Summary

T-1301 is a novel small-molecule inhibitor of multiple kinases being developed as an oral drug for the treatment of advanced solid tumors. The nonclinical study results demonstrate the nonclinical efficacy and safety of T-1301 and support the design of this Phase 1, first-in-human (FIH) clinical trial in subjects with advanced cancer.

This study is an open-label, multi-center, Phase I dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of T-1301 capsules in subjects with advanced solid tumors (including lymphoma), and to identify the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D). Approximately 30 patients will be enrolled for the dose-escalation phase. Actual number of patients will be determined by the number of dose cohorts until the MTD is reached.

T-1301 will be administered orally QD or BID in a 28-day cycle (21 days on treatment followed by 7 days off treatment) in sequential cohorts. Subjects can continue with the treatment until one of the discontinuation criteria is met or until the planned stop of the study (12 months after the last subject receives the first dose of study drug), whichever comes first.

The planned dose levels are: 10, 20, 40, 60, 80, 100, 120, 140 and 160 mg/day. The dosing schedule will be once daily (QD) at the first dose level (10 mg/day) and be changed to twice daily (BID) starting with the second dose level. Other dose levels or dosing frequency may be explored based on safety and related drug exposure data following the decision of Safety Review Committee.

The dose escalation will follow accelerated titration and the Bayesian optimal interval (BOIN) design. During the initial accelerated titration phase, one (1) subject is enrolled per dose level. In the subsequent phase when the BOIN design is used, subjects will be enrolled in cohorts of size 3-6.

Conditions

Interventions

DRUG

T-1301 Capsules

T-1301 Capsules, 10 and 50 mg, are opaque hard gelatin capsules for oral administration.

Sponsors & Collaborators

  • Taivex Therapeutics Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-19
Primary Completion
2027-01-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05156203 on ClinicalTrials.gov