Phase I Study of Safety and Immunogenicity of ADU-623 (NCT01967758) | Clinical Trial Compass
CompletedPhase 1
Phase I Study of Safety and Immunogenicity of ADU-623
United States11 participantsStarted 2014-01-08
Plain-language summary
This is a study for patients with brain tumors called astrocytic tumors. The study will enroll patients who have received standard treatment. The study will test a vaccine called ADU-623. ADU-623 has not been tested in humans before, so the goal of this study is to see if ADU-623 can be given safely to brain cancer patients and what is the better dose to give patients among the three doses that planned to be tested. This study will also evaluate the length of time before patients' cancer worsens and if ADU-623 helps patients to live longer. The study will also measure the body's immune system response to ADU-623.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients with a pathologic diagnosis of WHO Grade III or Grade IV astrocytic tumors that have completed standard of care or with radiographic evidence of progression following standard of care.
* Tumor tissue blocks available to perform both EGFRvIII and NY-ESO-1 testing
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or Karnofsky Performance Status (KPS) 70-100
* Age 18 years or above
* Have a life expectancy of more than 12 weeks
* Laboratory values (performed within 5 days) within designated range.
* For women and men of childbearing potential, an acceptable method of highly effective contraception
* Ability to give informed consent and comply with the protocol.
Exclusion Criteria:
* Have a known allergy to both penicillin and sulfa
* Have artificial (prosthetic) joint(s), orthopedic screw(s), metal plate(s) or other exogenous implant(s) or device(s) that cannot be easily removed (i.e., prosthetic heart valves).
* Have any evidence of hepatic cirrhosis or clinical or radiographic ascites.
* Have radiographic or clinically significant pleural effusion.
* Receipt of prophylactic vaccine within 28 days of study treatment.
* Unable to avoid close contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual).
* History of allergy to yeast or any other component of the ADU-623 vaccine (e.g., glycerol).
* Have an immunodeficiency disease or immunocompromised st…