Study of SC-003 Alone and in Combination With ABBV-181 in Subjects With Platinum-Resistant/Refractory Ovarian Cancer

Exclusion Criteria

• •History of prior malignancy, with the exception of the following: malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to screening and felt to be at low risk for recurrence by treating physician; or adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer; or adequately treated cervical carcinoma in situ without current evidence of disease.
• •Uncontrolled infection requiring systemic antibiotics/antivirals/antifungals
• •Evidence of complete or partial bowel obstruction
• •Patients requiring IV hydration or parenteral nutrition
• •Positive pregnancy test in females of child-bearing potential or pregnant or currently breastfeeding
• •Known hypersensitivity to any component of study drug including potential subjects with a history of major immunologic reaction to any IgG-containing agent
• •Inability to tolerate premedication with dexamethasone
• •Uncontrolled cardiac disease, or myocardial infarction within the last 12 months, or left ventricular ejection fraction (LVEF) \< 50%, or QTcF interval \> 470 msec
• •Class II, III or IV heart failure as defined by the NYHA functional class system
• •Positive serology for hepatitis B or C, or known human immunodeficiency virus infection (HIV)
• •Previous treatment with a pyrrolobenzodiazepine (PBD)-based drug
• •History of inflammatory bowel disease
• •Active autoimmune disease, with exceptions of psoriasis not requiring systemic treatment, vitiligo, type 1 diabetes mellitus and hypothyroidism
• •History of primary immunodeficiency, allogeneic bone marrow transplantation, solid organ transplantation, or previous clinical diagnosis of tuberculosis
• •History of immune-mediated pneumonitis
• •Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment