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Clinical Trial 18826
Cancer Type: Genitourinary
Study Type: Treatment
Phase of Study: Phase I
A Phase 1 Study of ALKS 4230 in Subjects with Advanced Solid Tumors
The purpose of this study is to find answers to the following research questions: * (Part A only) What is the highest dose of ALKS 4230 that can be given to participants when given for 5 days every 3 weeks? * Are there any side effects caused by taking ALKS 4230? * How much ALKS 4230 is in the blood at specific times after dosing and how does the body get rid of the ALKS 4230? * Does ALKS 4230 provide any benefit to people with advanced solid tumors?
Primary: To investigate the safety and tolerability of ALKS 4230 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of ALKS 4230 in subjects with advanced solid tumors who are refractory or intolerant to therapies known to provide clinical benefit. Secondary: To describe the dose-limiting toxicity (DLT) of ALKS 4230; To describe the adverse event (AE) profile of ALKS 4230; To characterize the clinical pharmacokinetic (PK) profile and immunogenicity of ALKS 4230; To investigate the clinical pharmacodynamic effects of ALKS 4230; To describe any antitumor activity and responses observed with ALKS 4230.