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A Study of CDX-1127 (Varlilumab) in Patients With Select Solid Tumor Types or Hematologic Cancers

Chronic Lymphocytic Leukemia Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

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 and T-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 dose escalation portion of the study will be assigned to one of 5 dose levels of CDX-1127. This 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 Expansion 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 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. ;

Study Design

Related Conditions & MeSH terms

  • Adenocarcinoma
  • Any T-cell Malignancy
  • Burkett's Lymphoma
  • Carcinoma, Non-Small-Cell Lung
  • CD27 Expressing B-cell Malignancies for Example Hodgkin's Lymphoma
  • Chronic Lymphocytic Leukemia
  • Colorectal Adenocarcinoma, Non-small Cell Lung Cancer)
  • Hodgkin Disease
  • Hormone-refractory Prostate Adenocarcinoma, Ovarian Cancer
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Mantle-Cell
  • Mantle Cell Lymphoma
  • Marginal Zone B Cell Lymphoma)
  • Melanoma
  • Neoplasms
  • Ovarian Neoplasms
  • Primary Lymphoma of the Central Nervous System
  • Prostatic Neoplasms
  • Solid Tumors (Metastatic Melanoma, Renal (Clear) Cell Carcinoma
Clinical Trial Details
NCT number NCT01460134
Study type Interventional
Source Celldex Therapeutics
Contact
Status Completed
Phase Phase 1
Start date October 2011
Completion date October 16, 2017
View Details
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