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

NCT ID: NCT02539719

Last Updated: 2019-01-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2019-01-02

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SC-003

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

Group Type: EXPERIMENTAL

SC-003

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

SC-003 in combination with ABBV-181

Intervention Type: DRUG

Interventions

SC-003

Intervention Type: DRUG

SC-003 in combination with ABBV-181

Intervention Type: DRUG

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stemcentrx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia Lawrence, D.O.

Role: STUDY_DIRECTOR

Novella Clinical

Locations

Fayetteville, Arkansas, United States

Duarte, California, United States

Chicago, Illinois, United States

Evanston, Illinois, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

Detroit, Michigan, United States

Rochester, Minnesota, United States

St Louis, Missouri, United States

New York, New York, United States

Columbus, Ohio, United States

Oklahoma City, Oklahoma, United States

Philadelphia, Pennsylvania, United States

Nashville, Tennessee, United States

Dallas, Texas, United States

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32513564 (View on PubMed)

Other Identifiers

SCRX003-001

Identifier Type: -

Identifier Source: org_study_id