Spots Global Cancer Trial Database for A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities

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Trial Identification

Brief Title: A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities

Official Title: 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

Study ID: NCT03410927

Conditions

Advanced Solid Tumors With HER2 Abnormalities

Advanced Solid Tumors With HER3 Abnormalities

Interventions

TAS0728

Study Description

Brief 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.

Detailed Description: