Phase 1 Study of Anti-OX40 in Patients With Advanced Cancer
This trial is active, not recruiting.
|Treatments||cohort 1 anti-ox40, cohort 2 anti-ox40, cohort 3 anti-ox40, tetanus day 29, tetanus day 1, klh day 1, klh day 29|
|Sponsor||Providence Health & Services|
|Start date||November 2003|
|End date||May 2009|
|Trial size||30 participants|
|Trial identifier||NCT01644968, 03-066A|
This study is designed to determine the safety and highest tolerated dose of anti-OX40 in patients with advanced cancer.
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
Dose limiting toxicity
time frame: 28 Days
time frame: Pre-study, Days 5, 8, 15, 29, 36, 43, and 57.
Male or female participants at least 18 years old.
Inclusion Criteria: - Patients with uncurable metastatic carcinoma, lymphoma, or sarcoma. - ECOG performance status 0, 1, 2 - No active bleeding - No clinical coagulopathy - Anticipated lifespan greater than 12 weeks Exclusion Criteria: - Active residual toxicity from prior therapies - Active Infection - HIV positive - Hepatitis B or C positive - Pregnant or nursing women - Requirement for oral steroids - Brain metastases - Presence or history of autoimmune disease - Shellfish or tetanus allergy - Splenomegaly - Lymph nodes greater than 10 cm in maximal diameter - Uncontrolled angina or class II or IV heart failure
|Official title||Phase 1 Trial of a Monoclonal Antibody to OX40 in Patients With Advanced Cancer.|
|Principal investigator||Brendan Curti, MD|
|Description||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.|
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