CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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 criteria
Qualifiers
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- negative by Herceptest (0 or 1+) or not amplified by in situ hybridization as per routine clinical testing.
Hormone receptor positive breast cancer for this study is defined as either estrogen receptor ≥10% or progesterone receptor ≥10% by immunohistochemistry, and HER2- negative by Herceptest (0 or 1+) or not amplified by in situ hybridization as per routine clinical testing.
Age 18 years or older
Disqualifiers
Among any patients enrolled in the first line treatment setting, tumors should not be PD-L1+ by 22C3 assays or eligible for FDA approved standard of care chemotherapy and anti-PD-1/PD-L1 combination therapy as alternative to this clinical trial. This does not apply if patients have previously received PD-1 or PD-L1 blockade as part of neoadjuvant or adjuvant therapy regimen.
History of severe hypersensitivity reactions to mAbs.
Prior treatment with any anti-CD40 antibody or rhuFlt3L product.
Treatment with anthracycline in the metastatic setting.
Trial design
Treatments tested in this trial
- PLD Chemotherapy
- CDX-1140
- CDX-301
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Texas Southwestern Medical Center
Lead sponsor
Celldex Therapeutics
Collaborator
Gateway for Cancer Research
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov