Ovarian Cancer Clinical Trial
Study of SC-003 Alone and in Combination With ABBV-181 in Subjects With Platinum-Resistant/Refractory Ovarian Cancer
Summary
This is a Phase 1a/1b study of SC-003 as a single agent and in combination with ABBV-181 in patients with platinum-resistant/refractory ovarian cancer. SC-003 is an antibody-drug conjugate (ADC) comprised of a monoclonal antibody linked to a potent chemotherapy. ABBV-181 is a humanized, recombinant, mAb that binds to cell surface expressed programmed cell death 1 (PD-1).
Full Description
Phase 1a is a dose escalation study in patients with histologically/cytologically confirmed ovarian cancer that are platinum-resistant or refractory. Phase 1b is an expansion study where patients will be enrolled and treated at recommended dose and schedule based on the Phase 1a.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed ovarian epithelial cancer
Evidence of progressive disease (PD) on or within 6 months of a platinum (cisplatin or carboplatin) regimen: at least 1 prior regimen must have contained a platinum-taxane combination
Measurable disease as defined by RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Fresh or archived tumor tissue sample available for target expression analysis. [Phase 1b only: Subjects' tumor tissue must test positive for target expression.]
Adequate hematologic and organ function as confirmed by laboratory values
At least 3 weeks between last systemic chemotherapy and planned start of study treatment (4 weeks for prior investigational drugs, immunotherapy, radiotherapy, or biologics) for ovarian cancer
At least 3 weeks between major surgery and planned start of study treatment; major incisions must have healed
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
Additional exclusion criteria for the SC-003 and ABBV-181 combination treatment regimen:
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
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There are 16 Locations for this study
Fayetteville Arkansas, 72703, United States
Duarte California, 91010, United States
Chicago Illinois, 60637, United States
Evanston Illinois, 60208, United States
Boston Massachusetts, 02114, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63130, United States
New York New York, 10065, United States
Columbus Ohio, 43210, United States
Oklahoma City Oklahoma, 73104, United States
Philadelphia Pennsylvania, 19111, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75230, United States
Houston Texas, 77030, United States
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