CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer
Phase 1 Pilot Study With Dose Expansion of Chemotherapy in Combination With CD40 Agonist and Flt3 Ligand in Metastatic HER2 Negative Breast Cancer
University of Texas Southwestern Medical Center
30 participants
Apr 20, 2022
INTERVENTIONAL
Conditions
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 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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
PLD chemotherapy will be administered 40 mg/m2 as intravenous injection once per cycle.
CDX-1140 will be administered 1.5mg/kg as intravenous injection once per cycle.
CDX-301 will be administered 75µg/kg as subcutaneous injection daily x 5 doses per cycle for 2 cycles.
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05029999