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A Phase 1, Open-label, Dose-escalation, Safety and Pharmacokinetic Study of CDX-1127 in Patients With Selected Refractory or Relapsed Hematologic Malignancies or Solid Tumors

Phase 1
18 Years
Open (Enrolling)
CD27 Expressing B-cell Malignancies, CD27 Expressing Solid Tumors, Chronic Lymphocytic Leukemia, Burkett's Lymphoma, Mantle Cell Lymphoma, Primary Lymphoma of the Central Nervous System, Marginal Zone B Cell Lymphoma, Solid Tumor, Metastatic Melanoma, Renal (Clear) Cell Carcinoma, Hormone-refractory Prostate Adenocarcinoma, Ovarian Cancer, Colorectal Adenocarcinoma, Non-small Cell Lung Cancer, Melanoma (Solid Tumor Expansion Arm Only)

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Trial Information

A Phase 1, Open-label, Dose-escalation, Safety and Pharmacokinetic Study of CDX-1127 in Patients With Selected Refractory or Relapsed Hematologic Malignancies or Solid Tumors

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, cohorts of approximately 15 patients each 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. Expansion cohorts may be limited to one or more tumor types.

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

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.

Inclusion Criteria:

Among other criteria, patients must meet the following conditions to be eligible for the

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. For the solid tumor expansion cohorts,
enrollment is limited to the following solid tumors: melanoma and renal cell

4. Tumor must be recurrent or treatment refractory with no remaining alternative,
approved therapy options, with the following exception: melanoma patients enrolled
in the expansion phase must have previously received ipilimumab and, for patients
with the BRAF V600E mutation, vemurafenib, or have been offered such therapies and
refused, and patients must have progressive disease subsequent to previous therapies.

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

Exclusion Criteria:

Among other criteria, patients who meet the following conditions are NOT eligible for the

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Characterize the adverse events associated with CDX-1127 administration

Outcome Description:

Analysis of adverse events along with the results of vital sign measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of CDX-1127.

Outcome Time Frame:

Until day 70 follow up.

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2011

Completion Date:

Related Keywords:

  • CD27 Expressing B-cell Malignancies
  • CD27 Expressing Solid Tumors
  • Chronic Lymphocytic Leukemia
  • Burkett's Lymphoma
  • Mantle Cell Lymphoma
  • Primary Lymphoma of the Central Nervous System
  • Marginal Zone B Cell Lymphoma
  • Solid Tumor
  • Metastatic Melanoma
  • Renal (Clear) Cell Carcinoma
  • Hormone-refractory Prostate Adenocarcinoma
  • Ovarian Cancer
  • Colorectal Adenocarcinoma
  • Non-Small Cell Lung Cancer
  • Melanoma (Solid Tumor Expansion Arm Only)
  • CD27 expressing Hematologic Malignancies
  • CD27 expressing Solid Tumors
  • chronic lymphocytic leukemia
  • Burkett's lymphoma
  • mantle cell lymphoma
  • primary lymphoma of the central nervous system
  • marginal zone B cell lymphoma
  • solid tumor
  • metastatic melanoma
  • renal (clear) cell carcinoma
  • hormone-refractory prostate adenocarcinoma
  • ovarian cancer
  • colorectal adenocarcinoma
  • non-small cell lung cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Carcinoma
  • Prostatic Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lung Neoplasms
  • Lymphoma
  • Melanoma
  • Ovarian Neoplasms
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Mantle-Cell
  • Hematologic Neoplasms
  • Colorectal Neoplasms



Mayo Clinic Rochester, Minnesota  55905
University of Virginia Health System Charlottesville, Virginia  22903
Sarah Cannon Research Institute Nashville, Tennessee  37203
Mary Crowley Cancer Research Centers - Medical City Dallas, Texas  75201
The Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210
Mayo Clinic Arizona - Cancer Clinical Research Unit Scottsdale, Arizona  85259
Stanford Cancer Center - Stanford University Stanford, California  94305