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

Primary Purpose

Ovarian Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SC-003

SC-003 in combination with ABBV-181

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Platinum-Resistant, Refractory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

SC-003

SC-003 in combination with ABBV-181

Arm Description

Phase 1a (Escalation) - IV infusion Phase 1b (Expansion) - IV infusion

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

Outcomes

Primary Outcome Measures

Adverse Events

Secondary Outcome Measures

Overall Response Rate

Pharmacokinetics of SC-003: AUC (area under the curve)

Pharmacokinetics of SC-003: Cmax (maximum concentration)

Pharmacokinetics of SC-003: Tmax (time of maximum concentration)

Pharmacokinetics of SC-003: Ctrough (concentration at trough)

Pharmacokinetics of SC-003: T1/2 (terminal half life)

Pharmacokinetics of SC-003: CL (clearance)

Pharmacokinetics of SC-003: Vss (volume of distribution at steady state)

Full Information

NCT ID

NCT02539719

First Posted

August 26, 2015

Last Updated

January 2, 2019

Sponsor

Stemcentrx

1. Study Identification

Unique Protocol Identification Number

NCT02539719

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Terminated

Why Stopped

Strategic Considerations

Study Start Date

August 2015 (undefined)

Primary Completion Date

January 2, 2019 (Actual)

Study Completion Date

January 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stemcentrx

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer

Keywords

Platinum-Resistant, Refractory

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SC-003

Arm Type

Experimental

Arm Description

Phase 1a (Escalation) - IV infusion Phase 1b (Expansion) - IV infusion

Arm Title

SC-003 in combination with ABBV-181

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

SC-003

Intervention Type

Drug

Intervention Name(s)

SC-003 in combination with ABBV-181

Primary Outcome Measure Information:

Title

Adverse Events

Time Frame

18 months (Phase 1a/1b)

Secondary Outcome Measure Information:

Title

Overall Response Rate

Time Frame

18 months (Phase 1a/1b)

Title

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)

Title

Pharmacokinetics of SC-003: Cmax (maximum concentration)

Time Frame