Phase
Condition
Metastatic Cancer
Treatment
pING-hHER3FL
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Documented history of solid tumor where HER3 expression is expected (this includesbreast, colon, lung, prostate, ovarian, cervical, endometrial, gastric, pancreatic,bladder, head and neck, liver, and esophageal cancer, but other tumors will beconsidered based on emerging HER3 expression data in the literature). Demonstrationof HER3 expression is not required for enrollment.
Has undergone surgical resection of malignancy and has completed intended standardcourse of chemotherapy and HER2 targeted therapy and radiotherapy under thedirection of their physician. Subjects may continue on adjuvant hormonal therapy.
Has no evidence of disease by standard imaging studies (performed at the directionof their physician) within 60 days prior to initiating study treatment.
Between 3 weeks and 2 years since prior cytotoxic chemotherapy, HER2-targetedtherapy or radiotherapy to the start of study treatment.
ECOG 0 or 1
Estimated life expectancy > 3 months.
Age ≥ 18 years.
Adequate hematologic function, with ANC >1500/µL, Hemoglobin ≥ 9 g/dL, and Platelets ≥ 75,000/µL.
Adequate renal and hepatic function, with Serum Creatinine < 1.5 mg/dL, Bilirubin < 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL),ALT and AST ≤ 2.5 x ULN or if liver metastases are present < 5 x ULN.
Female patients must be of non-child-bearing potential or use effectivecontraception, .
Labs performed as standard of care prior to signing consent can be used to fulfilleligibility requirements if they were performed within 4 weeks of the start of studytreatment.
Ability to understand and provide signed informed consent.
Ability to return to the study site for adequate follow-up, as required by thisprotocol.
Negative serum pregnancy test within 7 days prior to the start of study treatment,for women of childbearing potential only.
Exclusion
Exclusion Criteria:
Patients must have recovered to Grade 1 toxicities from any prior treatment(s).
Known CNS/brain metastases
History of auto-immune disease such as, but not restricted to, inflammatory boweldisease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, ormultiple sclerosis.
Serious chronic or acute illness considered by the Principal Investigator toconstitute an unwarranted high risk for investigational treatment.
Medical or psychological impediment to probable compliance with the protocol.
Concurrent or prior second malignancy (within the past 5 years) other thannon-melanoma skin cancer, Carcinoma in situ of the bladder and cervix.
Presence of active infection or systemic use of antimicrobials within 48 hours priorto the start of study treatment.
Patients on continuous steroid therapy for at least 72 hours (or other continuousimmunosuppressives such as azathioprine or cyclosporine A) are excluded on the basisof potential immune suppression.
Presence of a known active acute or chronic infection including HIV or viralhepatitis (Hepatitis B and C).
Pregnant or nursing women.
Prior immunotherapy
Study Design
Study Description
Connect with a study center
Duke University Medical Center
Durham, North Carolina 27710
United StatesActive - Recruiting
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