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

Overview

About this study

The purpose of this Phase 1a/1b study of SC-003 in patients with platinum-resistant/refractory ovarian cancer is to characterize the safety and tolerability of SC-003, identify the maximum tolerated dose (MTD) of SC-003, and identify the recommended Phase 1b dosing(s) and schedule(s) of SC-003.  SC-003 is an antibody-drug conjugate (ADC) comprised of a monoclonal antibody linked to a potent chemotherapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.
  • 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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Andrea Wahner Hendrickson, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions