Clinical Trial 18826

Cancer Type: Genitourinary
Interventions:ALKS 4230

Study Type: Treatment
Phase of Study: Phase I
Investigators:


    Overview

    Study Title

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

    Summary

    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?

    Objective

    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.

    Inclusion Criteria

  • For Part A, the participant has histological or cytological evidence of a solid tumor; for Part B, the participant has histological or cytological evidence of 1 of the following solid tumor types: melanoma, renal cell carcinoma, or ovarian cancer.
  • All participants must have advanced solid tumors that have returned after treatment with established approved therapies or be intolerant of established therapies.
  • Participants enrolled in Part B must have at least 1 lesion that may qualify as a target lesion.
  • Participant can move around on their own, has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and has an estimated life expectancy of at least 3 months.
  • Must have adequate hematologic reserve.
  • Must have adequate liver function.
  • Must have adequate kidney function.
  • Must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy or surgery.
  • Potential participants who have received investigational agents must wait at least 4 weeks.
  • Females of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and on Day 1 before the first dose is administered.
  • Meets contraceptive requirements defined in the protocol.
  • Additional criteria may apply.

  • Exclusion Criteria

  • Is currently pregnant or breastfeeding, or is planning to become pregnant during the study.
  • An active infection or with a fever >/+ 38.5 degrees C within 3 days of the first scheduled day of dosing for Cycle 1.
  • Active or symptomatic central nervous (CNS) system metastases. Potential participants with CNS system metastases are eligible for the study if the metastases have been treated by surgery and/or radiation therapy, the participant is off corticosteroids for at least 2 weeks and is neurologically stable.
  • Have a mean QT interval corrected by the Fridericia Correction formula value of >470 msec (in females) or >450 msec (in males).
  • A known hypersensitivity to any components of ALKS 4230.
  • Require pharmacologic doses of corticosteroids; replacement doses, topical, ophthalmologic, and inhalational steroids are permitted.
  • Developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and neuropathy.
  • Any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the subject to cooperate and participate in the study.
  • Known to be positive for human immunodeficiency virus (HIV), hepatitis B or C.
  • Additional criteria may apply.