Clinical Trials Search
A Phase 1 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination with Pembrolizumab 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.