MC# 19-35 - A Phase I/II Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

  • Agent(s): ALKS 4230
  • Disease Type(s): Melanoma, Solid Tumor, Renal, Lung-NSCLC, Squamous Cell Carcinoma of Head and Neck
  • Phase(s): I, II
  • Drug Classification(s): Cytokines
  • Molecular Target(s): Intermediate-affinity IL-2R

Mechanism of Action

ALKS4230 is a selective effector cell activator, which binds and activates IL-2.  This activates and increases the number of immune cells that work to eliminate cancer cells.


In this study, the sponsor and investigators want to learn:

  • About the safety and tolerability of ALKS 4230
  • How proteins that indicate the status of your disease are affected with use of ALKS 4230
  • How much of ALKS 4230 is absorbed into the blood and how fast it is removed
  • If your body develops proteins that work against ALKS 4230
Inclusion Criteria
  1. The subject or the subject’s legal representative is willing and able to provide written informed consent
  2. The subject is aged ≥18 years
  3. For Part A, the subject has histological or cytological evidence of a solid tumor; for Part B, the subject has a diagnosis of melanoma or renal cell carcinoma
  4. All subjects must have advanced solid tumors that have returned after treatment with established approved therapies or be intolerant of established therapies
  5. Subjects enrolled in Part B or Part C must have at least 1 lesion that may qualify as a target lesion
  6. Subject 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
  7. Subject must have adequate hematologic reserve
  8. Subjects must have adequate liver function
  9. Subjects must have adequate kidney function
  10. Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy or surgery
  11. Subjects who have received investigational agents must wait at least 4 weeks
  12. 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.  A female not of childbearing potential is one who has undergone bilateral oophorectomies or who is postmenopausal, defined as >45 years of age and without a menstrual period for 12 consecutive months.
  13. Meets contraceptive requirements defined in the protocol
Exclusion Criteria
  1. Subject is currently pregnant or breastfeeding, or is planning to become pregnant during the study
  2. Subjects with an active infection or with a fever >/+ 38.5 degrees C within 3 days of the first scheduled day of dosing for Cycle 1
  3. Subjects with active or symptomatic central nervous system metastases are excluded.  Subjects with central nervous system metastases are eligible for the study if the metastases have been treated by surgery and/or radiation therapy, the subject is off corticosteroids for at least 2 weeks and the subject is neurologically stable.
  4. Subjects have a mean QT interval corrected by the Fridericia Correction formula value of >470 msec (in females) or >450 msec (in males)
  5. Subjects with known hypersensitivity to any components of ALKS 4230
  6. Subjects with known hypersensitivity to any components of pembrolizumab (for patients in combination arm only)
  7. Subjects who require pharmacologic doses of corticosteroids; replacement doses, topical, ophthalmologic, and inhalational steroids are permitted
  8. Subjects who developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and neuropathy
  9. Subjects with 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
  10. The subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B or C, or active tuberculosis, or has a known history of tuberculosis


  • Dallas, TX - Mary Crowley Cancer Research - Medical City
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Re: MC# 19-35