CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 114 target
Drug / intervention
TSN084drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06386705
NCT06386705Phase 1RecruitingUpdate OverdueUpdated 23mo ago · Completion was 6mo ago
Enrollment Stalled
Long Recruiting
Update Overdue

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.

Tyligand Bioscience (Shanghai) Limited·interventional·Posted Apr 26, 2024·Updated Jul 29, 2024

In Brief

A Phase 1 clinical trial evaluating TSN084 for Malignant Neoplasm. Currently recruiting, targeting 114 participants across 2 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 1RecruitingOverdue
2023202420252026
First PostedApr 26, 2024
Enrollment StartJul 20, 2022
Primary CompletionDec 30, 2025
Study CompletionJun 30, 2026
TodayJul 1, 2026
Enrollment to primary: 3.4 yearsPosted 2.2 years ago

Interventions

TSN084drug

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