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Brief Title: CD40 Agonist, Flt3 Ligand, and Chemotherapy in Triple Negative Breast Cancer
Official Title: Phase 1 Pilot Study With Dose Expansion of Chemotherapy in Combination With CD40 Agonist and Flt3 Ligand in Metastatic Triple Negative Breast Cancer
Study ID: NCT05029999
Brief Summary: 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 negative breast cancer, and to determine a safe dose and treatment schedule of the three drugs. This research study will also test how these treatments improve your body's immune response against the cancer.
Detailed Description: The immunotherapy drugs CDX-301 and CDX-1140 in combination with the standard chemotherapy treatment PLD work by kickstarting the immune response against cancer cells. CDX-301 increases the antigen presenting immune cells needed to kickstart the immune response, CDX-1140 activates these cells, and chemotherapy helps release antigens from the cancer cells to train these antigen presenting immune cells to recognize the cancer for the immune system to attack it. Metastatic or unresectable triple negative breast cancer patients will receive this triplet combination that has been shown in preclinical studies to be more effective than the individual treatments or doublet combinations. To understand how the immunotherapies are working, some patients will receive the immunotherapy or chemotherapy only for one cycle prior to receiving the full triplet combination therapy. Ultimately, all patients will receive the triplet combination to study safety and how effective this treatment is at controlling triple negative breast cancer and improving survival outcomes.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Johns Hopkins University, Baltimore, Maryland, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Texas Oncology, P.A., Dallas, Texas, United States
UT Southwestern Medical Center, Dallas, Texas, United States
The University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Name: Sangeetha Reddy
Affiliation: UT Southwestern Medical Center
Role: PRINCIPAL_INVESTIGATOR