MC# 17-37 - A Phase I/IIa Study of BMS-986179 Administered Alone and in Combination with Nivolumab (BMS-936558) in Subjects with Advanced Solid Tumors

  • Agent(s): BMS-986179, Nivolumab
  • Disease Type(s): Melanoma, Renal, Prostate, Lung-NSCLC, Head and Neck
  • Phase(s): I
  • Drug Classification(s): Targeted Therapy, Immunotherapy, Monoclonal Antibody
  • Molecular Target(s): CD73

Mechanism of Action

CD73 is an ectoenzyme in the tumor microenvironment that generates adenosine, an immunosuppressive molecule, and promotes tumor growth.  BMS-986179 is a high-affinity antibody that efficiently inhibits CD73 function. Inhibiting CD73, enhances innate and immunotherapy-induced anti-tumor immune response in a variety of tumor cell types.

Purpose

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

  • How much BMS-986179 can be given with an acceptable level of side effects when given alone or with Nivolumab
  • The safety and tolerability of BMS-986179 when given alone or with Nivolumab
  • How much BMS-986179 and Nivolumab is absorbed into the blood and how fast they are removed when given together
  • If research tests can be used in the future to predict who will benefit from BMS-986179
  • How proteins that indicate the status of disease are affected with use of BMS-986179 when given with Nivolumab
  • If the body develops proteins that work against BMS-986179 when given alone or given with Nivolumab
Inclusion Criteria
  • Men and women at least 18 years of age
  • Advanced solid tumors
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Acceptable lab testing results
  • Allow biopsies
Exclusion Criteria
  • Central nervous system (CNS) tumors
  • Uncontrolled or significant cardiovascular diseases
  • Active or known autoimmune disease
  • Organ transplant

Other protocol defined inclusion/exclusion criteria could apply

Location

  • Dallas, TX - Mary Crowley Cancer Research - Medical City
More Info: https://www.clinicaltrials.gov/ct2/show/NCT02754141?term=NCT02754141&rank=1

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Re: MC# 17-37