NCT04830501

Study of the of the Safety and Tolerability of TT-00434 in Patients With Advanced Solid Tumors

A Phase I Study of the Safety, Tolerability, Pharmacokinetics Profile, and Preliminary Efficacy of TT-00434 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: TransThera Sciences (Nanjing), Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I study of the safety, tolerability, pharmacokinetics profile, and preliminary efficacy of TT-00434 in patients with advanced solid tumors.

Detailed description

This is a phase I, First-in-Human (FIH), open-label, dose escalation clinical study in patients who have a histological or cytologically confirmed diagnosis of advanced or recurrent tumors that all standard treatments have been used or are not feasible. It aims to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) for study, evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics and the preliminary anti-tumor activity of TT-00434, and explore the relationship between the anti-tumor activity of TT-00434 and the tumor FGFR alterations.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	TT-00434	Once daily \[QD\], 28 days/cycle.

Timeline

• Start date: 2021-07-12
• Primary completion: 2023-10-18
• Completion: 2023-10-18
• First posted: 2021-04-05
• Last updated: 2023-11-21

Locations

3 sites across 1 country: Taiwan