A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma
This study is being conducted to examine survival, safety, and the magnitude of the immune response induced following administration of DN24-02 in subjects with HER2+ urothelial carcinoma.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- biological : DN24-02
- other : Standard of Care
Phase: Phase 2
Ages Eligible For Study:
- Histopathologic evidence of urothelial carcinoma at high risk of recurrence. - Radical surgical resection was performed ? 84 days (12 weeks) prior to registration. - No evidence of residual disease or metastasis on CT scan of chest, abdomen and pelvis obtained at least 28 days following surgical resection and ? 28 days prior to registration. - HER2/neu tissue expression ? 1+ by immunohistochemistry (IHC). Available biopsy specimens from the primary tumor and involved lymph nodes are be submitted to the central pathology laboratory prior to registration for confirmation of HER2/neu tissue expression. - Last neoadjuvant chemotherapy treatment administered at least 60 days prior to registration. - Left ventricular ejection fraction ? 50% on MUGA scan or echocardiogram obtained at least 28 days following surgery and ? 28 days prior to registration. - Women of child-bearing potential have a negative serum pregnancy test result ? 28 days prior to registration and agree not to breastfeed during investigational treatment with DN24-02 and for 28 days following the final infusion of DN24-02. - All males and premenopausal females who have not been surgically sterilized have agreed to practice a method of birth control considered by the Investigator to be effective and medically acceptable for at least 14 days prior to registration, throughout treatment, and for 28 days following the final infusion of DN24-02. - Adequate hematologic, renal, and liver function. - Eastern Cooperative Oncology Group (ECOG) performance status ? 2.