Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06386705

TSN084 Treating Patients With Advanced Malignant Tumors

Led by Tyligand Bioscience (Shanghai) Limited · Updated on 2024-07-29

114

Participants Needed

2

Research Sites

205 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

TSN084 Treating Patients With Advanced Malignant Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men or women 18 years or older
  • Able to understand the study and provide written informed consent
  • Able to follow medication and study procedures and considered reliable
  • Histological or cytological diagnosis of locally advanced, relapsed, or metastatic malignancies not suitable for or lacking standard therapy
  • For phase Ib, diagnosis of selected malignancies with disease progression or intolerance to standard therapy; malignancies with targeted mutations preferred
  • Expected survival of at least 12 weeks
  • ECOG performance status 0 to 1 for phase Ia, 0 to 2 for phase Ib
  • Adequate organ function at screening
  • Male and female patients of childbearing potential agree to use effective contraception
Not Eligible

You will not qualify if you...

  • Active brain metastases requiring corticosteroids or unstable CNS disease
  • Other malignancies within 5 years except certain treated skin, breast, cervical, or bladder cancers with no recurrence
  • Arterial thromboembolic events within 6 months prior to enrollment
  • Uncontrolled third space effusion requiring repeated drainage
  • Active gastrointestinal disease or conditions affecting drug absorption or metabolism
  • Pregnant or lactating women
  • History of allogeneic organ or stem cell transplantation
  • HIV infection
  • Active syphilis or tuberculosis infection
  • History of drug abuse or drug use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

2

Peking university cancer hospital

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

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Research Team

T

Tyligand Clinical Trial Info

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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