QUILT-3.013: Study of Ad5 [E1-, E2b-]-HER2/Neu Vaccine (ETBX-021) in Subjects With Unresectable Lā¦ (NCT02751528) | Clinical Trial Compass
TerminatedPhase 1
QUILT-3.013: Study of Ad5 [E1-, E2b-]-HER2/Neu Vaccine (ETBX-021) in Subjects With Unresectable Locally Advanced or Metastatic HER2-Expressing Breast Cancer
Stopped: Due to low enrollment
United States3 participantsStarted 2017-03-04
Plain-language summary
The purpose of this study is to determine whether ETBX-021 is safe and effective in the treatment of unresectable locally advanced or metastatic HER2-low-expressing breast cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Age ā„ 18 years.
ā. Male or female.
ā. Ability to understand and provide signed informed consent that fulfills Institutional Review Board (IRB)'s guidelines.
ā. Histologically confirmed unresectable locally advanced or metastatic breast cancer that expresses HER2 (IHC 1+ or 2+), derived from the most recent metastatic biopsy sample available.
ā. Tumor tissue (block or slides) and whole blood sample available for analysis. Archival tissue is permitted.
ā. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
ā. Concurrent hormone therapy is permitted.
ā. Subjects who have received prior HER2-targeted immunotherapy (vaccine) are eligible for this trial if this treatment was discontinued at least 3 months prior to enrollment.
Exclusion criteria
ā. Subjects with HER2 IHC 3+ tumors, or IHC 2+ with an in situ hybridization (ISH) test result considered positive of HER2 amplification by ASCO-CAP HER2 test guidelines.
ā. Subjects with ongoing HER2-directed therapy, including trastuzumab, pertuzumab, T-DM1, and lapatinib.
ā. Participation in an investigational drug or device study within 30 days of screening for this study.
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What they're measuring
1
Number of Participants With Treatment-emergent Adverse Events, Number of Participants With Treatment Emergent Serious Adverse Events, and Number of Participants With Dose Limiting Toxicities (DLTs)
Timeframe: Up to 12 months
2
Determine the Maximum Tolerated Dose (MTD) or Highest Tested Dose (HTD)
ā. Subjects with ongoing palbociclib, everolimus, or other breast cancer therapy that interferes with the induction of immune responses.
ā. Subjects with concurrent cytotoxic chemotherapy or radiation therapy. There must be at least 1 month between any other prior chemotherapy (or radiotherapy) and study treatment. Any prior HER2-targeted immunotherapy (vaccine) must have been discontinued at least 3 months before initiation of study treatment. Subjects must have recovered from all acute toxicities from prior treatment prior to screening for this study.
ā. Active brain or central nervous system metastasis, seizures requiring anticonvulsant treatment, cerebrovascular accident (\< 6 months), or transient ischemic attack.
ā. Subjects with a history of autoimmune disease (active or past), such as but not restricted to inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Autoimmune-related thyroid disease and vitiligo are permitted.