CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer (NCT05029999)
Phase 1 Pilot Study With Dose Expansion of Chemotherapy in Combination With CD40 Agonist and Flt3 Ligand in Metastatic HER2 Negative Breast Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Chicago Comprehensive Cancer Center — Chicago, Illinois
Age range: 18 Years to 99 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (7 Sites)
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois
- Johns Hopkins University — Baltimore, Maryland
- University of North Carolina — Chapel Hill, North Carolina
- Sarah Cannon Research Institute — Nashville, Tennessee
- Texas Oncology, P.A. — Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas
- The University of Texas Health Science Center at San Antonio — San Antonio, Texas
📞 Contact the Study Coordinator
Phone: (214) 648-7020
Email: Meredith.carter@utsouthwestern.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in HER2-negative Breast Cancer
- A Ph II Study of the TheraBionic P1 Device in Subjects With Hormone Positive Breast Cancer — Bay City, Michigan
- DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Breast Cancer Patients — Jacksonville, Florida
- Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer — San Francisco, California
- Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC) — Bethesda, Maryland
Explore by condition: All HER2-negative Breast Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.