Study Stopped
Strategic Considerations
Study of SC-003 Alone and in Combination With ABBV-181 in Subjects With Platinum-Resistant/Refractory Ovarian Cancer
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
1 other identifier
interventional
74
1 country
16
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 ovarian-cancer
Started Aug 2015
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 26, 2015
CompletedFirst Posted
Study publicly available on registry
September 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2019
CompletedJanuary 4, 2019
January 1, 2019
3.4 years
August 26, 2015
January 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Events
18 months (Phase 1a/1b)
Secondary Outcomes (8)
Overall Response Rate
18 months (Phase 1a/1b)
Pharmacokinetics of SC-003: AUC (area under the curve)
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)
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)
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)
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 more secondary outcomes
Study Arms (2)
SC-003
EXPERIMENTALPhase 1a (Escalation) - IV infusion Phase 1b (Expansion) - IV infusion
SC-003 in combination with ABBV-181
EXPERIMENTALPhase 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stemcentrxlead
Study Sites (16)
Unknown Facility
Fayetteville, Arkansas, 72703, United States
Unknown Facility
Duarte, California, 91010, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Evanston, Illinois, 60208, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Detroit, Michigan, 48201, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Rochester, Minnesota, 55905, United States
Unknown Facility
St Louis, Missouri, 63130, United States
Unknown Facility
New York, New York, 10065, United States
Unknown Facility
Columbus, Ohio, 43210, United States
Unknown Facility
Oklahoma City, Oklahoma, 73104, United States
Unknown Facility
Philadelphia, Pennsylvania, 19111, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Dallas, Texas, 75230, United States
Unknown Facility
Houston, Texas, 77030, United States
Related Publications (1)
Hamilton E, O'Malley DM, O'Cearbhaill R, Cristea M, Fleming GF, Tariq B, Fong A, French D, Rossi M, Brickman D, Moore K. Tamrintamab pamozirine (SC-003) in patients with platinum-resistant/refractory ovarian cancer: Findings of a phase 1 study. Gynecol Oncol. 2020 Sep;158(3):640-645. doi: 10.1016/j.ygyno.2020.05.038. Epub 2020 Jun 6.
PMID: 32513564DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Julia Lawrence, D.O.
Novella Clinical
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2015
First Posted
September 3, 2015
Study Start
August 1, 2015
Primary Completion
January 2, 2019
Study Completion
January 2, 2019
Last Updated
January 4, 2019
Record last verified: 2019-01