Phase 1 Dose-Escalation Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases
Patients who consented to participate in the study were 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 qualified for the study received a
single intravenous dose of CRS-100 on study day 1, after which they remained in the hospital
for five days for safety monitoring of health status, including serial blood collections.
Study participants returned for out-patient follow-up for further blood tests and additional
monitoring of safety and immune response to CRS-100. At day 56, after administration of
CRS-100, participants had a repeat CT scan to measure tumor size, and they were then
discharged from the study.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicities (DLTs) for 7 days after dosing
United States: Food and Drug Administration
|Johns Hopkins University||Baltimore, Maryland 21205|
|Mary Crowley Medical Research Center||Dallas, Texas 75246|