This study is designed to determine the safety and highest tolerated dose of anti-OX40 in patients with advanced cancer.
This study will evaluate the safety and determine the maximal tolerated dose of anti-OX40; evaluated the immune response to the study treatment; measure the pharmacokinetics of anti-OX40; monitor tumor regression, and identify the most biologically active dose of anti-OX40 to induce antigen-specific responses to a variety of immunogens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
0.1 mg/kg anti-OX40 on days 1, 3, and 5
.4 mg/kg anti-OX40 on days 1, 3, and 5
2.0 mg/kg anti-OX40 on days 1, 3, and 5
Providence Cancer Center
Portland, Oregon, United States
Dose limiting toxicity
A dose limiting toxicity is defined as any grade \>=3 hematologic (except lymphopenia) or non-hematologic toxicity (except hypothyroidism or vitiligo) that, in the opinion of the investigator is considered at lease possibly related to the study treatment. If DLT is observed in greater than two patient in any cohort, then the previous cohort will be the maximal tolerated dose.
Time frame: 28 Days
Immune Response
Blood tests and leukapheresis product will be collected to determine the response to three types of reporter antigens: (1) new antigen (keyhole limpet hemocyanin (KLH)), (2) recall protein antigen (tetanus), and (3) viral antigen (cytomegalovirus (CMV)). Changes in the number of antigens will be used to determine immune response.
Time frame: Pre-study, Days 5, 8, 15, 29, 36, 43, and 57.
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Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 29
Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 1.
1 mg KLH in 1 cc diluent subcutaneously on Day 1.
1 mg KLC in 1 cc diluent by subcutaneous injection on Day 29.