• Home
  • Study Details
Open

Phase 1 pilot study with dose expansion of chemotherapy in combination with CD40 agonist and Flt3 ligand in metastatic triple negative breast cancer

You are asked to participate in this research study of a new immunotherapy combination with chemotherapy in metastatic triple negative breast cancer. Immunotherapy is a form of cancer therapy that activates a patient's immune system to fight the cancer in a patient's body. Unfortunately, only a limited number of patients with metastatic triple negative breast cancer currently respond to FDA approved forms of immunotherapy. CDX-301 and CDX-1140 are two new immunotherapy drugs that are thought to kickstart the immune response against cancers even in patients who do not have an adequate immune response against their cancer to start with. Some studies suggest that combining these drugs with chemotherapy can most effectively kickstart this immune response and lead to improved clinical outcomes.

Age & Gender

  • 18 years ~ 99 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

You will have test, exams and procedures that are part of your standard care and for study purposes. While you are taking part in this study, you will be asked to attend between two and five visits per cycle with the researchers or study staff. This study involves blood draws, biopsies, physical exams, scans, pregnancy testing (if female), ECG and ECHO or MUGAs, completion of questionnaires and receipt of study medication. Patient who complete study treatment will move into long term follow up and will be contacted at regular intervals by the study team.

Incentives

Hotel stay reimbursement will be provided up to $750 per cycle with your CDX-301 injections. Receipts will need to be provided to the study team for processing of this reimbursement.

Total length of participation:
Varies from 1 day to 10 years. Depending on how you respond to treatment

Looking for Specific Volunteers

Able to participate:

  • You have been diagnosed with either unresectable triple negative breast cancer, or metastatic triple negative breast cancer
  • Your cancer has progressed during or following your most recent treatment for your cancer
  • You agree to utilize effective contraception during the course of the study and 6 months following the end of study treatment, if you are a

Not eligible if:

  • You have active, untreated central nervous system metastases of your breast cancer
  • You have received chemotherapy within 21 days prior to starting the study treatment
  • You have had major surgery within 4 weeks of starting the study treatment.
  • You have had prior treatment for your breast cancer with an anthracycline (such as Doxil) for your metastatic breast cancer
  • You have a prior history of acute myeloid leukemia (AML) or a tumor with a known FLT3 mutation

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Yara Abdou
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Breast)

IRB Number

23-2746

ClinicalTrials.gov

NCT05029999

Research for Me logo

Copyright © 2013-2022 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH.  This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.

Questions?

  • This email address is being protected from spambots. You need JavaScript enabled to view it.
logo for the North Carolina Translational and Clinical Sciences Institute
logo for UNC Health
logo for UNC School of Medicine
logo for UNC Research