Phase 1 study of DS-8201a in subject with Advanced Solid Malignant Tumors

Recruitment & Eligibility

Status: completed

Sex: All

Target Recruitment: 32

Inclusion Criteria

1.Has a pathologically documented unresectable or metastatic solid malignant tumors with HER2 expression (determined by immunohistochemistry [IHC]/in situ hybridization [ISH] [IHC 3+, IHC 2+, IHC 1+, and/or ISH +], Next Generation Sequencing, or other analysis techniques as appropriate) that is refractory to or intolerable with at least 1 prior systemic chemotherapy regimen, or for which no standard treatment is available.
2. LVEF >= 50% .
3. Has an ECOG PS 0 or 1.

Exclusion Criteria

1.Has a contraindication for receiving ritonavir or itraconazole according to the prescribing information.
2.Has a medical history of myocardial infarction within 6 months before enrollment, symptomatic congestive heart failure.
3.Has complications of ventricular arrhythmia

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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Phase 1 study of DS-8201a in subject with Advanced Solid Malignant Tumors

Recruitment & Eligibility

Study & Design

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