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



Status:Active, not recruiting
Conditions:Skin Cancer, Cancer, Brain Cancer, Thyroid Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:3/21/2019
Start Date:September 2016
End Date:September 2020

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An Open-Label Study of Rovalpituzumab Tesirine in Subjects With Delta-Like Protein 3-Expressing Advanced Solid Tumors

To assess the safety and tolerability of rovalpituzumab tesirine in subjects with specific
delta-like protein 3-expressing advanced solid tumors.

This is a multicenter, open-label study involving multiple specific advanced solid tumor
types, consisting of a dose escalation Part A followed by an expansion Part B. Cancer
subtypes will be studied in separate disease-specific cohorts in both Parts. Eight separate
cohorts will enroll malignant melanoma, medullary thyroid cancer (MTC), glioblastoma, large
cell neuroendocrine carcinoma (LCNEC), neuroendocrine prostate cancer (NEPC), high-grade
gastroenteropancreatic (GEP), neuroendocrine carcinoma (NEC), other NEC, and solid tumors
other than the above.

Inclusion Criteria:

- Histologically confirmed, unresectable advanced solid malignancy with documented
disease progression after at least 1 prior systemic therapy

- Measurable disease as defined by RECIST 1.1

- 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:

1. Chemotherapy, small molecule inhibitors, radiation, and/or other investigational
anticancer agents (excluding investigational monoclonal antibodies): 2 weeks.

2. Immune-checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, or anti-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.

Exclusion Criteria:

- 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 (see Appendix 12.4) within 6 months prior to
their first dose of study drug.

- Recent or ongoing serious infection, including:

1. Any active grade 3 or higher (per NCI CTCAE version 4.03) viral, bacterial, or
fungal infection within 2 weeks of the first dose of the study drug. Routine
antimicrobial prophylaxis is permitted.

2. Known seropositivity for or active infection by human immunodeficiency virus
(HIV).

3. 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
We found this trial at
28
sites
Lexington, Kentucky
859) 257-9000
Principal Investigator: Anthony Lowell, MD
Phone: 866-340-4488
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Christine Hann, MD
Phone: 410-464-6713
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Anna Farago, MD
Phone: 877-420-3951
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Grace K Dy, MD
Phone: 877-275-7724
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Andrew Hendifar, MD
Phone: 310-423-2133
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Allan Pantuck, MD
Phone: 310-794-7700
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Matthew Taylor, MD
Phone: 503-494-1080
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Heloisa Soares, MD
Phone: 888-663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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1365 Clifton Road
Atlanta, Georgia 30322
Principal Investigator: Taofeek Owonikoko, MD
Phone: 404-778-1868
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Karl Lewis, MD
Phone: 720-848-0637
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Cleveland, Ohio 44012
Principal Investigator: Afshin Dowlati, MD
Phone: 800-641-2422
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Dallas, Texas 75246
Principal Investigator: John Nemunaitis, MD
Phone: 972-566-3000
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Denver, Colorado 80218
Principal Investigator: Gerald Falchook, MD
Phone: 720-754-2610
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Durham, North Carolina 27710
Principal Investigator: Tian Zhang, MD
Phone: 919-684-6342
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Principal Investigator: Alexander I Spira, MD
Phone: 703-280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Fort Worth, Texas 76104
Principal Investigator: Stephen Richey, MD
Phone: 817-850-2230
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Gainesville, Florida 32610
Principal Investigator: Frederic J Kaye, MD
Phone: 352-273-8675
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Gilbert, Arizona 85234
Principal Investigator: Jiaxin Niu, MD
Phone: 855-256-6444
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Greenville, South Carolina 29615
Principal Investigator: Ki Young Chung, MD
Phone: 864-455-7070
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Houston, Texas 77030
Principal Investigator: David S. Hong
Phone: 855-590-5652
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New Brunswick, New Jersey 08903
Principal Investigator: Jyoti Malhotra, MD
Phone: 732-235-8675
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New York, New York 10065
Principal Investigator: Himisha Beltran, MD
Phone: 646-962-8215
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Phoenix, Arizona 85054
Principal Investigator: Alan Bryce, MD
Phone: 855-776-0015
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Rochester, Minnesota 55905
Principal Investigator: Aaron Mansfield, MD
Phone: 507-284-2511
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Saiama Waqar, MD
Phone: 314-362-1000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Salt Lake City, Utah 84112
Principal Investigator: Jonathan Whisenant, MD
Phone: 888-424-2100
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San Francisco, California 94143
Principal Investigator: Rahul Aggarwal, MD
Phone: 877-827-3222
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Vancouver, Washington 98683
Principal Investigator: David Smith, MD
Phone: 360-944-9889
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