Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors

Stopped early · Phase 1/Phase 2

Conditions studied: Malignant Melanoma, Medullary Thyroid Cancer, Glioblastoma, Large-Cell Neuroendocrine Carcinoma, Neuroendocrine Prostate Cancer, High Grade Gastroenteropancreatic Neuroendocrine Carcinoma, Other Neuroendocrine Carcinoma, Other Solid Tumors

In brief

The primary objective of this study is to assess the safety and tolerability of rovalpituzumab tesirine in subjects with specific delta-like protein 3-expressing advanced solid tumors.

Key facts

Study ID

NCT02709889

Run by

AbbVie

People needed

200

Starts

2016-09-23

Expected to finish

2019-08-27

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed, unresectable advanced solid malignancy with documented disease progression after at least 1 prior systemic therapy
• Disease is relapsed/refractory to prior standard systemic therapy or for which standard or curative therapy does not exist or is not considered appropriate by the Investigator.
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Delta-like protein 3 (DLL3)-expressing malignancy based on central immunohistochemical (IHC) testing of representative baseline tumor tissue (archived tissue or on-study biopsy). Positive is defined as staining in ≥ 1% of tumor cells.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Minimum life expectancy of at least 12 weeks
• Subjects with a history of central nervous system (CNS) metastases must have documentation of stable or improved brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of Study Drug, off or on a stable dose of corticosteroids. Definitive treatment may include surgical resection, whole brain irradiation, and/or stereotactic radiation therapy. (Applicable to tumor types of non-CNS primary origin only)
• Recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration
• Adequate hematologic and organ function as confirmed by laboratory values
• Last dose of any prior therapy administered by the following time intervals before the first dose of study drug:
• Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks.
• Immune-checkpoint inhibitors (e.g., anti-programmed death protein 1 [PD-1], anti-programmed death-ligand 1 [PD-L1], or anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA-4]), monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies: 4 weeks (2 weeks with documented disease progression).
• Females of childbearing potential must have a negative beta human chorionic gonadotropin (β-hCG) pregnancy test result within 7 days prior to the first dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.

You may not qualify if…

• Any significant medical condition, including any suggested by screening laboratory findings that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study, including but not necessarily limited to uncontrolled hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization within 3 months) or neurological disorder (e.g., seizure disorder active within 3 months).
• Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior to their first dose of study drug.
• Recent or ongoing serious infection, including:
• Any active grade 3 or higher (per National Cancer Institute Common Terminology Criteria for Adverse Events version [NCI CTCAE] 4.03) viral, bacterial, or fungal infection within 2 weeks of the first dose of the study drug. Routine antimicrobial prophylaxis is permitted.
• Known seropositivity for or active infection by human immunodeficiency virus (HIV).
• Active Hepatitis B (by surface antigen expression or polymerase chain reaction) or C (by polymerase chain reaction) infection or on hepatitis-related antiviral therapy within 6 months of first dose of study drug.
• Women who are pregnant or breastfeeding
• Systemic therapy with corticosteroids at >20 mg/day prednisone or equivalent within 1 week prior to the first dose of study drug
• History of another invasive malignancy that has not been in remission for at least 3 years. Exceptions to the 3year limit include non-melanoma skin cancer, curatively treated localized prostate cancer, ductal carcinoma in situ, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on pap smear.
• Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation, unless undergoing retreatment with rovalpituzumab tesirine in the context of this protocol

Where it is running

• Banner MD Anderson Cancer Ctr /ID# 155424 — Gilbert, Arizona, United States
• Mayo Clinic - Scottsdale /ID# 155419 — Scottsdale, Arizona, United States
• University of California, Los Angeles /ID# 155429 — Los Angeles, California, United States
• Univ California, San Francisco /ID# 155409 — San Francisco, California, United States
• Cedars-Sinai Medical Center - West Hollywood /ID# 155428 — West Hollywood, California, United States
• Univ of Colorado Cancer Center /ID# 155415 — Aurora, Colorado, United States
• Sarah Cannon Research Institute at HealthONE - Denver /ID# 155420 — Denver, Colorado, United States
• University of Florida - Archer /ID# 155414 — Gainesville, Florida, United States
• Moffitt Cancer Center /ID# 170220 — Tampa, Florida, United States
• Emory University Hospital /ID# 155417 — Atlanta, Georgia, United States
• University of Kentucky Chandler Medical Center /ID# 155423 — Lexington, Kentucky, United States
• Johns Hopkins University /ID# 155412 — Baltimore, Maryland, United States
• Massachusetts General Hospital /ID# 155411 — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute /ID# 171044 — Boston, Massachusetts, United States
• Mayo Clinic - Rochester /ID# 155416 — Rochester, Minnesota, United States
• Washington University-School of Medicine /ID# 155425 — St Louis, Missouri, United States
• Rutgers Cancer Institute of NJ /ID# 162010 — New Brunswick, New Jersey, United States
• University of New Mexico /ID# 205054 — Albuquerque, New Mexico, United States
• Roswell Park Comprehensive Cancer Center /ID# 162015 — Buffalo, New York, United States
• Weill Cornell Medical College /ID# 155418 — New York, New York, United States
• Duke University Medical Center /ID# 155421 — Durham, North Carolina, United States
• Univ Hosp Cleveland /ID# 155410 — Cleveland, Ohio, United States
• Oregon Health and Science University /ID# 162011 — Portland, Oregon, United States
• Greenville Hospital System /ID# 155427 — Greenville, South Carolina, United States
• Mary Crowley Cancer Research /ID# 162014 — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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