A Phase 1, Open-Label, Dose-Escalation, Multiple Dose Study of the Safety, Tolerability, and Immune Response of CRS-207 in Adult Subjects With Selected Advanced Solid Tumors Who Have Failed or Who Are Not Candidates for Standard Treatment
Patients who consent to participate in the study will be evaluated for eligibility according
to their medical history, physical examination, blood testing, and computed tomography (CT)
scan of thorax, abdomen, and pelvis. Those patients who qualify for the study will receive
up to 4 intravenous doses of CRS-207, 21 days apart. After each infusion, they will be
monitored overnight in an in-patient facility, including collection of blood specimens.
Study participants will return after each infusion for outpatient follow-up visits for
further blood tests and additional monitoring of safety and immune response to CRS-207.
Participants will have repeat CT scans to measure tumor size after the 2nd dose and again
after the 4th dose. On Day 91 participants will be discharged from the study. All study
participants will be eligible to participate in a long-term follow-up study with a visit 6
months after the final dose of CRS-207 and annually thereafter for evaluation of disease
progression, survival, and potential long-term toxicity of CRS 207.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicities related to the investigational agent
28 days after first dose
Anza Therapeutics, Inc.
United States: Food and Drug Administration
|The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University||Baltimore, Maryland 21231|
|National Cancer Institute, NCI||Bethesda, Maryland 20892|
|University of Pennsylvania Abramson Family Cancer Research Center||Philadelphia, Pennsylvania 19104|