Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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