NCT06386705

TSN084 Treating Patients With Advanced Malignant Tumors

A Multicenter, Open-label, Phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of TSN084 Tablets in Patients With Advanced Malignant Tumors.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Tyligand Bioscience (Shanghai) Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

TSN084 is a novel type II kinase inhibitor with demonstrated anti-tumor effects in vitro and in vivo and targets multiple tyrosine kinases, such as c-MET, FLT3, TRK and serine/threonine kinase CDK8/19. This phase 1a/1b study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of TSN084 in advanced or metastatic malignancies in China.

Detailed description

The phase 1a part will begin with an exploration of TSN084 dose and regimen to determine the maximum tolerated dose (MTD) and/or recommended dose for further investigation (i.e., RP2D). In Phase 1b part, separate cohorts of patients with different histological diagnosis will be evaluated for the clinical activity and efficacy of TSN084 at the recommended dose.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
DRUG	TSN084	TSN084 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.

Timeline

• Start date: 2022-07-20
• Primary completion: 2025-12-30
• Completion: 2026-06-30
• First posted: 2024-04-26
• Last updated: 2024-07-29

Locations

2 sites across 1 country: China