A Phase 1 Study of ALKS 4230 in Subjects with Advanced Solid Tumors

Brief description of study

This is a multicenter, open-label, Phase 1 study which will be conducted in 2 parts: a dose-escalation part and a dose expansion part. Patients with advanced melanoma, renal cell carcinoma, non-small cell lung cancer (NSCLC), bladder cancer, ovarian cancer, and triple negative breast cancer will be considered for this study. In the dose-escalation part of the study, patients will receive ALKS 4230, an investigational drug by intravenous (IV) administration daily for 5 days, followed by 16 days off, for a total of 21 days (3 weeks) for each cycle. For the first 2 treatment cycles, subjects will receive ALKS 4230 as inpatients at a medical facility with immediate access to the intensive care unit (ICU) and medical support measures.


Clinical Study Identifier: s15-01394
ClinicalTrials.gov Identifier: NCT02799095
Principal Investigator: Vamsidhar Velcheti
Currently Recruiting

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