A Phase 1 Study of RTX-321 for the Treatment of Patients with Advanced Malignancies Associated with Human Papillomavirus-16 Infection

Are you eligible to participate in this study?

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

  • Conditions:
    Advanced Malignancies Associated With Human Papillomavirus-16 Infection
  • Age: Between 18 years - 100 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Histologically confirmed diagnosis by the local laboratory of persistent, recurrent, ormetastatic, unresectable cervical cancer (squamous, adeno, or adenosquamous histology),HNSCC, or squamous cell cancer of the anal canal that is not amenable to curative therapy. 2) All patients must have experienced disease progression following platinum-based ormitomycin C-based chemotherapy administered in the persistent, recurrent, or metastatic setting.

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

  • 1) Patient has central nervous system (CNS) involvement. If the patient fulfills the following 3 criteria, she/he is eligible for the trial after consultation with the SponsorMedical Monitor. a.Completed prior therapy for CNS metastases (radiation and/or surgery) b.CNS tumor(s) is clinically stable at the time of enrollment c.Patient does not require corticosteroid or antiepileptic therapy for management of CNS metastases. 2) Known hypersensitivity to any component of study treatment, including excipients 3.Clinically significant, active, uncontrolled infection including HIV, or hepatitis B or Cvirus (HBV; HCV).


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