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.
- 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
- 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
- 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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