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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

This is a study of CDX-1127, a therapy that targets the immune system and may act to promote anti-cancer effects. The study enrolls patients with hematologic cancers (certain leukemias and lymphomas), as well as patients with select types of solid tumors.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : CDX-1127

Phase: Phase 1

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

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 or T-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 carcinoma. 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.

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Contact information

Primary Contact:

Jennifer Vargas 650-723-0371

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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