CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer

This research study is being done to find out if the immunotherapy drugs called CDX-301 and CDX-1140 in combination with the standard chemotherapy treatment pegylated liposomal doxorubicin (PLD, Doxil) are safe and effective at controlling the cancer in patients with metastatic triple Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer, and to determine a safe dose and treatment schedule of the three drugs. This research study will also test how your immune system responds to these treatments alone and in combination.

Trial Details

NCT ID
NCT05029999
Phase
PHASE1
Sponsor
University of Texas Southwestern Medical Center
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • PLD Chemotherapy
  • CDX-1140
  • CDX-301
Locations (sample)
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • Chapel Hill, North Carolina, United States|35.9132,-79.05584
  • Nashville, Tennessee, United States|36.16589,-86.78444
  • Dallas, Texas, United States|32.78306,-96.80667

Key Eligibility Criteria

  • Unresectable Stage III or Stage IV HER2 negative breast cancer (either triple negative or hormone receptor positive)
  • Triple negative breast cancer for this study is defined as estrogen receptor \<10%, progesterone receptor \<10% by immunohistochemistry, and HER2- …
  • Hormone receptor positive breast cancer for this study is defined as either estrogen receptor ≥10% or progesterone receptor ≥10% by immunohistochem…
  • Age 18 years or older

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

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