CDX-1127 is a fully human monoclonal antibody that binds to a molecule called CD27 found on certain immune cells and also on certain hematologic tumor cells and may act to promote anti-tumor effects.
This study will evaluate the safety and activity of escalating doses of CDX-1127 in patients with B-cell hematologic malignancies known to express CD27 and solid tumors that are more likely to be responsive to the immune system.
Eligible patients who enroll in the study will be assigned to one of 5 dose levels of CDX-1127. The first phase of the study will test the safety profile of CDX-1127 and will assess which dose to test in future studies.
During the second phase, up to 30 patients will receive the study treatment to continue to evaluate the safety profile of CDX-1127 and to determine if it has an effect on their cancer. Patients enrolled in the study may receive study treatment for up to 5 cycles, until their disease has progressed or until it is necessary to stop the treatment for safety or other reasons.
All patients enrolled in the study will be closely monitored to determine if their cancer is responding to treatment and for any side effects that may occur.
Among other criteria, patients must meet the following conditions to be eligible for the study:
1. 18 years of age or older
2. Body Weight ≤ 120 kg
3. Histologic diagnosis of either a B-cell hematologic malignancy known to express CD27 or one of the following solid tumors: metastatic melanoma, renal (clear) cell carcinoma, hormone-refractory prostate adenocarcinoma, ovarian cancer, colorectal adenocarcinoma or non-small cell lung cancer
4. Tumor must be recurrent or treatment refractory with no remaining alternative, approved therapy options
5. Measurable or evaluable disease
6. Have adequate blood, bone marrow, liver and kidney function as determined by laboratory tests.
7. If of childbearing potential (male or female), agree to practice an effective form of contraception during study treatment.
8. Have little or no side effects remaining from prior cancer therapies.
9. Provide written informed consent
Among other criteria, patients who meet the following conditions are NOT eligible for the study:
1. Known prior primary or metastatic brain or meningeal tumors
2. Receiving treatment with immunosuppressive agents, including any systemic steroids.
3. Active infection requiring systemic therapy, known HIV infection, or positive test for hepatitis B surface antigen or hepatitis C
4. Is being treated for anti-coagulation (i.e. warfarin) for reasons other than catheter patency
5. Women who are pregnant or lactating
6. Prior allogeneic bone marrow transplant
7. Autologous bone marrow transplant within 100 days of first dosing
8. Recent chemotherapy or other anti-cancer therapy (within 2 - 14 weeks depending on treatment type)
9. Systemic radiation therapy within 4 weeks or prior focal radiotherapy within 2 weeks prior to first dosing
Last updated: 12/04/2012