Learn More about CDX-1127

CDX-1127: Clinical Program

CLINICAL PROGRAM FOR HEMATOLOGIC MALIGNANCIES AND SOLID TUMORS

CDX-1127 is an agonist anti-CD27 monoclonal antibody (mAb) that is expected to activate CD27 expressing T cells in the context of T cell receptor stimulation. In addition to the immune enhancing properties of CDX-1127, the mAb may also provide direct therapeutic effects against tumors with CD27 expression. CDX-1127 is in Phase 1 development for the treatment of B cell hematologic malignancies known to express CD27, including but not limited to chronic lymphocytic leukemia (CLL), Burkett’s lymphoma, mantle cell lymphoma, primary lymphoma of the central nervous system and marginal zone B-cell lymphoma and solid tumors that may be more likely to be sensitive to immune therapy: metastatic melanoma, renal cell carcinoma, hormone-refractory prostate adenocarcinoma, ovarian cancer, colorectal adenocarcinoma or non-small cell lung cancer (NSCLC).

Now Enrolling
Phase 1, Dose-Escalation Study of CDX-1127 in Patients with Hematologic Malignancies and Solid Tumors
Design: Phase 1, open-label, dose-escalation study of CDX-1127
Status: Currently enrolling at multiple centers in the US

About the Clinical Trial

This Phase 1 trial will examine the safety, pharmacokinetics, immune response and anti-tumor 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 of the study, 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.

Patient Eligibility

Among other criteria, patients must meet all of the following conditions to be eligible to be in the study:

  • 18 years of age or older
  • Body Weight ≤ 120 kg or 265 lbs
  • 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
  • Tumor must be recurrent or treatment refractory with no remaining alternative, approved therapy options
  • Measurable or evaluable disease
  • Have adequate blood, bone marrow, liver and kidney function as determined by laboratory tests
  • If of childbearing potential (male or female), agree to practice an effective form of contraception during study treatment
  • Have little or no side effects remaining from prior cancer therapies
  • Provide written informed consent
Exclusion Criteria:

Among other criteria, patients who meet any of the following conditions are NOT eligible to be in the study:

  • Known prior primary or metastatic brain or meningeal tumors
  • Receiving treatment with immunosuppressive agents, including any systemic steroids
  • Active infection requiring systemic therapy, known HIV infection, or positive test for hepatitis B surface antigen or hepatitis C
  • Being treated for anti-coagulation (i.e. warfarin) for reasons other than catheter patency
  • Women who are pregnant or lactating
  • Bone marrow transplant within 100 days of first dosing
  • Recent chemotherapy or other anti-cancer therapy (within 2 - 14 weeks depending on treatment type)
  • Systemic radiation therapy within 4 weeks or prior focal radiotherapy within 2 weeks prior to first dosing
  • Any underlying medical condition that, in the Principal Investigator's opinion, will make the administration of study drug hazardous or otherwise interfere with the study

Please click here for more information about this trial, including a list of clinical trial sites and contact information for prospective patients.

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