Trials / Active Not Recruiting
Active Not RecruitingNCT05300438
Phase I Study of TSN084 in 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
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 74 (estimated)
- Sponsor
- Tyligand Bioscience (Shanghai) Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TSN084 | Oral tablets |
Timeline
- Start date
- 2022-02-18
- Primary completion
- 2025-03-01
- Completion
- 2025-06-01
- First posted
- 2022-03-29
- Last updated
- 2024-06-25
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05300438. Inclusion in this directory is not an endorsement.