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Clinical Trial Summary

This is a study to determine the maximum tolerated dose (MTD) for CDX-1140 (CD40 antibody), either alone or in combination with CDX-301 (FLT3L), pembrolizumab, or chemotherapy and to further evaluate its tolerability and efficacy in expansion cohorts once the MTD is determined.


Clinical Trial Description

This study will determine the MTD of CDX-1140 while also evaluating the safety, tolerability and efficacy of CDX-1140 alone (Part 1) or in combination with CDX-301 (Part 2), pembrolizumab (Part 3), or chemotherapy (Part 4) in patients with cancer. Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-1140. The dose-escalation part of the study will test the safety profile of CDX-1140, alone or in combination with CDX-301, pembrolizumab or chemotherapy and determine which dose(s) of CDX-1140 will be studied in the expansion portions of the study. All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur. ;


Study Design


Related Conditions & MeSH terms

  • Bladder Urothelial Carcinoma
  • Breast Cancer
  • Carcinoma
  • Cholangiocarcinoma
  • Colorectal Cancer
  • Diffuse Large B-cell Lymphoma (DLBCL)
  • Esophageal Cancer
  • Fallopian Tube Cancer
  • Fallopian Tube Neoplasms
  • Follicular Lymphoma
  • Gastric Cancer
  • Head and Neck Cancer
  • Hepatic Cancer
  • Indolent B-cell Lymphomas
  • Liver Neoplasms
  • Lung Neoplasms
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-Cell
  • Lymphoma, Non-Hodgkin
  • Lymphoplasmacytic Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Melanoma
  • Mucosa Associated Lymphoid Tissue
  • Non-Hodgkin Lymphoma
  • Non-small Cell Lung Cancer
  • Other Solid Tumors
  • Ovarian Cancer
  • Pancreatic Adenocarcinoma
  • Primary Peritoneal Cancer
  • Renal Cell Carcinoma
  • Small Lymphocytic Leukemia
  • Waldenstrom Macroglobulinemia
  • Waldenstrom's Disease

NCT number NCT03329950
Study type Interventional
Source Celldex Therapeutics
Contact
Status Completed
Phase Phase 1
Start date December 1, 2017
Completion date September 13, 2022

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