Trials / Terminated
TerminatedNCT03410927
A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities
A Phase 1/2, Open Label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of TAS0728, an Oral Covalent Binding Inhibitor of HER2, in Subjects With Advanced Solid Tumors With HER2 or HER3 Abnormalities
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Taiho Oncology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a First-in-Human (FIH), 2-part, Phase 1/2, open-label, multicenter study design to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of TAS0728. This study consists of Phase 1 and Phase 2 components in subjects with advanced solid tumors with HER2 or HER3 overexpression, amplification, or mutation who have progressed despite standard therapy or for which no standard therapy exists, particularly urothelial cancer, biliary tract cancer, metastatic breast cancer, non-small cell lung cancer and colorectal cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TAS0728 | TAS0728 is an oral HER2 covalent inhibitor investigated in patients with advanced solid tumor harboring HER2 or HER3 abnormalities. It will be administered orally at a starting dose of 50 mg BID each morning and evening and escalated to the DLT. The MTD will be used for the phase 2 arms of the study. |
Timeline
- Start date
- 2018-04-06
- Primary completion
- 2022-06-09
- Completion
- 2022-06-09
- First posted
- 2018-01-25
- Last updated
- 2024-09-05
Locations
8 sites across 4 countries: United States, France, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03410927. Inclusion in this directory is not an endorsement.