Phase I Study of TSN084 in Patients With Advanced Malignant Tumors.
NCT05300438 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74
Last updated 2024-06-25
Summary
TSN084 is a novel type II protein 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 first-in-human 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.
Conditions
- Cancer (With or Without Metastasis)
Interventions
- DRUG
-
TSN084
Oral tablets
Sponsors & Collaborators
-
Tyligand Bioscience (Shanghai) Limited
lead INDUSTRY
Principal Investigators
-
Siqing Fu, MD, PhD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-18
- Primary Completion
- 2025-03-31
- Completion
- 2025-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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