Phase 1 Trial of a Monoclonal Antibody to 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.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Brendan Curti, MD
Providence Health & Services
United States: Food and Drug Administration
|Providence Cancer Center||Portland, Oregon 97213-2933|