Multiple Ascending Dose (MDX1105-01) (Anti-PDL1)
Status and phase
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Treatments
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Details and patient eligibility
About
Collection of survival data, evaluation of PDL-1 expression in tumors, and evaluation of PD-L1 receptor occupancy in peripheral blood has been added.
Full description
This is an open label, multicenter, dose escalation and multidose study of MDX-11-5, a fully human monoclonal IgG4 antibody targeting the Programed Death-Ligand 1 (PD-L1).
The study will consist of 3 periods: Screening (up to 28 days), Treatment (up to 16 six-week cycles), and Follow-up (up to 6 months).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
- The malignancies include relapsed/refractory renal cell carcinoma, non-small cell lung cancer, colorectal adenocarcinoma, malignant melanoma, advanced/metastatic epithelial ovarian cancer, gastric cancer, pancreatic cancer and breastcancer
- Must have measurable disease
Exclusion criteria
- Prior therapy with an anti-PD 1, anti-PDL 1, or anti-Cytotoxic T-Lymphocyte Antigen 4 antibody (or any other agents that target T-cell co-stimulation)
Trial design
Primary purpose
Allocation
Interventional model
Masking
281 participants in 5 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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