Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Study of SC-003 in Subjects With Platinum-Resistant/Refractory Ovarian Cancer

Protocol: OSU-15137

Full Title

A Phase Ia/Ib Dose Escalation and Expansion Study of Single-Agent SC-003 in Subjects with Platinum-Resistant/Refractory Ovarian Cancer

Purpose

This is a Phase 1a/1b study of SC-003 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.

Study Objective

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.

Are you eligible?

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 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 - Peripheral neuropathy ≥ grade 2 - Radiotherapy > 25% of bone marrow prior to initiation of therapy - 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 - 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

Ovarian Cancer Gynecologic Cancers