An Open Label Phase 1 Dose-Escalation Study to Evaluate the Safety and Preliminary Antitumor Activity of TAK-676 with Pembrolizumab Following Radiation Therapy in the Treatment of Non-Small-Cell Lung Cancer Triple-Negative Breast Cancer or Squamous Cell Carcinoma of the Head and Neck that has Progressed on Checkpoint Inhibitors

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Nsclc, Tnbc, Or Hnscc
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 2) Patients must have at least 2 measurable RECIST v.1.1-evaluable lesions, with at least one inside and at least one other outside of the radiation field. 3) The tumor outside the radiation field must be accessible for biopsy, and the patient must consent to tumor biopsy at screening and during treatment.

You may not be eligible for this study if the following are true:

  • 1) History of brain metastasis unless: a) Clinically stable, (ie, treatment completed 2:4 weeks prior) following prior surgery, whole-brain radiation, or stereotactic radiosurgery, AND b) Off corticosteroids. 2) Known history of uncontrolled autoimmune disorders, HIV infection, or other relevant congenital or acquired immunodeficiencies. 3) Chronic, active hepatitis ( eg, patients with known hepatitis B surface antigen seropositive and/or detectable hepatitis C virus [HCV]-RNA). 4) Contraindication and/or history of intolerance to the administration of checkpoint inhibitors.


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