Actively Recruiting
CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer
Led by University of Texas Southwestern Medical Center · Updated on 2025-08-13
30
Participants Needed
7
Research Sites
208 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
C
Celldex Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Unresectable Stage III or Stage IV HER2 negative breast cancer (triple negative or hormone receptor positive)
- Triple negative breast cancer defined as estrogen receptor <10%, progesterone receptor <10%, and HER2-negative
- Hormone receptor positive breast cancer defined as estrogen receptor 6510% or progesterone receptor 6510%, and HER2-negative
- Performance status ECOG 0-2
- Life expectancy of at least 12 weeks
- Documented progressive disease after last anticancer therapy
- For triple negative breast cancer: first to fourth line treatment setting with 0 to 3 prior regimens for metastatic or unresectable disease
- For hormone receptor positive breast cancer: prior cyclin dependent kinase inhibitor in metastatic setting, and up to 3 prior lines of chemotherapy and/or antibody drug conjugates
- PD-L1 negative by 22C3 assay if triple negative breast cancer in first line treatment setting and not eligible for FDA approved chemotherapy and anti-PD-1/PD-L1 combination
- Laboratory values meeting specified limits for neutrophils, platelets, hemoglobin, creatinine, liver enzymes, bilirubin, and alkaline phosphatase
- Agreement to effective contraception during and for 6 months after study treatment if applicable
- Consent for pre-treatment and on-treatment biopsies from accessible tumor lesions
- Measurable disease by RECIST 1.1 criteria
- Resolution of prior therapy toxicities to grade 1 or less (with exceptions)
You will not qualify if you...
- PD-L1 positive tumors eligible for FDA approved chemotherapy and anti-PD-1/PD-L1 therapy in first line treatment setting (unless prior PD-1/PD-L1 therapy in neoadjuvant or adjuvant treatment)
- History of severe hypersensitivity to monoclonal antibodies
- Prior treatment with anti-CD40 antibody or recombinant human Flt3 ligand
- Anthracycline treatment in metastatic setting or progression within 6 months after neoadjuvant/adjuvant anthracycline
- History of acute myeloid leukemia or tumor with Flt3 mutation/amplification
- Recent use of checkpoint inhibitors, monoclonal therapies, immunotherapies, or T-cell/cell-based therapies within specified time frames
- Recent systemic radiation, focal radiotherapy, or radiopharmaceuticals within specified time frames
- Recent chemotherapy, antibody drug conjugates, or kinase inhibitors within specified time frames
- Major surgery within 4 weeks before study treatment
- Use of investigational drugs within 4 weeks or 5 half-lives
- Use of immunosuppressive medications or corticosteroids within specified time frames
- Other prior malignancies except treated skin cancers or in situ cancers, or cancers disease-free for at least 3 years
- Active untreated or unstable treated brain metastases
- Pregnancy or nursing; females must have negative pregnancy test
- Active autoimmune disease requiring systemic treatment within 6 months except specified exceptions
- Significant cardiovascular disease or recent major cardiac events
- Prior anthracycline therapy exceeding cumulative dose limits without cardiology evaluation
- Live vaccine within 30 days prior to study drug
- History or current pneumonitis
- Active infection requiring systemic therapy or positive HIV/hepatitis tests
- Any other medical or psychiatric condition increasing risk or interfering with study participation
- Evidence of infection on screening chest X-ray
AI-Screening
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Trial Site Locations
Total: 7 locations
1
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
2
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
3
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
4
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Withdrawn
5
Texas Oncology, P.A.
Dallas, Texas, United States, 75251
Active, Not Recruiting
6
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
7
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
M
Meredith Carter, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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