Study of SC-003 Alone and in Combination With ABBV-181 in Subjects With Platinum-Resistant/Refractory Ovarian Cancer
Status: | Terminated |
---|---|
Conditions: | Ovarian Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/6/2019 |
Start Date: | August 2015 |
End Date: | January 2, 2019 |
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
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).
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).
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.
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.
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
We found this trial at
15
sites
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