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

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ClinicalTrials.gov Identifier: NCT02539719
Recruitment Status : Terminated (Strategic Considerations)
First Posted : September 3, 2015
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Stemcentrx

Brief 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).

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: SC-003 Drug: SC-003 in combination with ABBV-181 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a/1b Dose Escalation and Expansion Study of SC-003 as a Single-Agent and in Combination With ABBV-181 in Subjects With Platinum-Resistant/ Refractory Ovarian Cancer
Study Start Date : August 2015
Actual Primary Completion Date : January 2, 2019
Actual Study Completion Date : January 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: SC-003
Phase 1a (Escalation) - IV infusion Phase 1b (Expansion) - IV infusion
Drug: SC-003
Experimental: SC-003 in combination with ABBV-181
Phase 1a (Escalation) - IV infusion of SC-003 followed by IV infusion of ABBV-181 Phase 1b (Expansion) - IV Infusion of SC-003 followed by IV infusion of ABBV-181
Drug: SC-003 in combination with ABBV-181



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

Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 18 months (Phase 1a/1b) ]
  2. 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) ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539719


Locations
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United States, Arkansas
Fayetteville, Arkansas, United States, 72703
United States, California
Duarte, California, United States, 91010
United States, Illinois
Chicago, Illinois, United States, 60637
Evanston, Illinois, United States, 60208
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Michigan
Detroit, Michigan, United States, 48201
Detroit, Michigan, United States, 48202
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Missouri
Saint Louis, Missouri, United States, 63130
United States, New York
New York, New York, United States, 10065
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Dallas, Texas, United States, 75230
Houston, Texas, United States, 77030
Sponsors and Collaborators
Stemcentrx
Investigators
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Study Director: Julia Lawrence, D.O. Novella Clinical

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Responsible Party: Stemcentrx
ClinicalTrials.gov Identifier: NCT02539719     History of Changes
Other Study ID Numbers: SCRX003-001
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019

Keywords provided by Stemcentrx:
Platinum-Resistant
Refractory

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type