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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Stemcentrx
Sponsor:
Information provided by (Responsible Party):
Stemcentrx
ClinicalTrials.gov Identifier:
NCT02539719
First received: August 26, 2015
Last updated: June 27, 2016
Last verified: June 2016
  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.

Condition Intervention Phase
Ovarian Cancer
Drug: SC-003
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1a/1b Dose Escalation and Expansion Study of Single-Agent SC-003 in Subjects With Platinum-Resistant/Refractory Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Stemcentrx:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: 18 months (Phase 1a/1b) ]

Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: 18 months (Phase 1a/1b) ]
  • Pharmacokinetics of SC-003: AUC (area under the curve) [ Time Frame: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min) ]
  • Pharmacokinetics of SC-003: Cmax (maximum concentration) [ Time Frame: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min ]
  • Pharmacokinetics of SC-003: Tmax (time of maximum concentration) [ Time Frame: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min ]
  • Pharmacokinetics of SC-003: Ctrough (concentration at trough) [ Time Frame: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min ]
  • Pharmacokinetics of SC-003: T1/2 (terminal half life) [ Time Frame: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min ]
  • Pharmacokinetics of SC-003: CL (clearance) [ Time Frame: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min ]
  • Pharmacokinetics of SC-003: Vss (volume of distribution at steady state) [ Time Frame: Cycle 1 and 4: days 1 (pre-dose, post-dose: 30min, 6hr), 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 (pre-dose, post-dose: 30min ]

Estimated Enrollment: 108
Study Start Date: August 2015
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SC-003
Phase 1a (Escalation) - IV infusion Phase 1b (Expansion) - IV infusion
Drug: SC-003

Detailed 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02539719

Contacts
Contact: Stemcentrx Study Team SCRX003-001@stemcentrx.com
Contact: John H M Mei john.mei@stemcentrx.com

Locations
United States, Ohio
Recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Stemcentrx
Investigators
Study Director: Julia Lawrence, D.O. Novella Clinical
  More Information

Responsible Party: Stemcentrx
ClinicalTrials.gov Identifier: NCT02539719     History of Changes
Other Study ID Numbers: SCRX003-001
Study First Received: August 26, 2015
Last Updated: June 27, 2016

Keywords provided by Stemcentrx:
Platinum-Resistant
Refractory

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on April 24, 2017