Pegzilarginase and Pembrolizumab for Extensive Disease Small Cell Lung Cancer



Status:Recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/18/2019
Start Date:December 21, 2017
End Date:December 2020
Contact:Aeglea Clinical Department
Email:oncology@aegleabio.com
Phone:1.855.509.9921

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A Phase 1/2 Study of Pegzilarginase (AEB1102, Co-ArgI-PEG) in Combination With Pembrolizumab in the Treatment of Patients With Extensive Disease (ED) Small Cell Lung Cancer (SCLC)

The main purpose of this Phase 1/2 study is to determine the safety and efficacy of
pegzilarginase in combination with pembrolizumab in patients with ED-SCLC who have relapsed
or progressive disease on or within 6 months of platinum-based chemotherapy.


Key Inclusion Criteria:

1. Patient is able and willing to provide written informed consent

2. Be > 18 years of age on day of signing informed consent

3. Have histologically or cytologically confirmed SCLC that meets:

1. Extensive disease per criteria of the International Association for the Study of
Lung Cancer (IASLC)-American Joint Committee on Cancer (AJCC) TNM staging system

2. Have not tolerated or have progressed or relapsed on or within 6 months of
platinum-based chemotherapy

4. Have a performance status of ≤ 1 on the ECOG Performance Scale

5. Have measurable disease based on RECIST 1.1

6. Willing to undergo core needle or incisional biopsy to obtain fresh tumor tissue
specimens

7. Demonstrate adequate organ function as evidenced by laboratory testing with specimens
collected within 10 days prior to day 1 of cycle 1

8. Female child-bearing potential must have a negative urine or serum pregnancy test
within 72 hours prior to receiving the first dose of study medication

9. Sexually active male or female must be surgically sterile post-menopausal, or must
agree to use a physician-approved method of birth control during the study through a
minimum of 120 days after the last study drug administration.

Key Exclusion Criteria:

1. Has received more than 2 platinum-based regimens against SCLC

2. Has received pembrolizumab, or prior therapy with an anti-PD-1, anti-PD-L1,
anti-PD-L2, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody as
part of any previous therapy, including trials

3. Has participated in Merck MK-3475 (pembrolizumab) clinical trials

4. Has received pegzilarginase as part of any previous therapy

5. Is currently participating in a study of an investigational agent or received the last
dose of an investigational agent within 4 weeks prior to the first dose of treatment
in this study (a shorter interval for kinase inhibitors or other short half-life drugs
could be considered after approval from the Sponsor). Is currently participating in a
study of an investigational device within 4 weeks of the first dose of treatment

6. Has a diagnosis of an immunodeficiency, is receiving systemic steroid therapy (except
for physiological dose levels), or immunosuppressive therapies

7. Has a known additional malignancy that is progressing or has required active treatment
within the past 3 years. Exceptions include basal cell carcinoma of the skin, squamous
cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical
cancer) that has undergone potentially curative therapy

8. Has known central nervous system (CNS) metastases. However, patients with previously
treated brain metastases may participate provided neurologic symptoms have stabilized,
there is no evidence of new brain metastases or hemorrhage and they are not using
steroids for brain metastases or for complications derived from their treatment for at
least 7 days prior to the first dose of trial treatment

9. Has known carcinomatous meningitis

10. Has an active autoimmune disease requiring systemic treatment in the past 2 years
(i.e. with use of disease modifying agents, corticosteroids or immunosuppressive
drugs) or a documented history of clinically severe autoimmune disease, or a syndrome
that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or
resolved childhood asthma/atopy are an exception to this rule. Patients that require
intermittent use of bronchodilators or local steroid injections will not be excluded
from the study. Patients with hypothyroidism stable on hormone replacement or
Sjorgen's syndrome will not be excluded from the study. Replacement therapy (e.g.
thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or
pituitary insufficiency, etc) is not considered a form of systemic treatment

11. Has evidence of interstitial lung disease, history of non-infectious pneumonitis that
required steroids, or current pneumonitis

12. Inadequately controlled hypertension (defined as systolic blood pressure ≥ 200 mmHg
and/or diastolic blood pressure ≥ 120 mmHg) on more than one occasion in the month
before planned day of infusion

13. Currently taking 3 or more anti-hypertensive medications

14. Prior history of hypertensive crisis or hypertensive encephalopathy

15. History of myocardial infarction, unstable angina, cardiac or other vascular stenting,
angioplasty, or cardiac or vascular surgery within 6 months prior to day 1 of study
treatment

16. Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the pre-screening or screening visit
through 120 days after the last dose of trial treatment

17. Has a known history of Human Immunodeficiency Virus (HIV) (positive for HIV p24
antigen or HIV 1/2 antibodies)

18. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA
[qualitative] is detected)

19. Has a known history of active tuberculosis (Bacillus tuberculosis)

20. Has had an allogenic tissue/solid organ transplant.
We found this trial at
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sites
Niles, Illinois 60714
Principal Investigator: David Hakimian, MD
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Taofeek Owonikoko, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Shirish Gadgeel, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Aurora, Colorado 80045
Principal Investigator: Ross Camidge, MD
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Blacksburg, Virginia 24060
Principal Investigator: Jerome Goldschmidt, MD
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Charleston, South Carolina 29403
Principal Investigator: Brian Lingerfelt, MD
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Charlotte, North Carolina 28211
Principal Investigator: Daniel Carrisoza, MD
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Chattanooga, Tennessee 37403
Principal Investigator: Robert Graham, MD
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Principal Investigator: David Waterhouse, MD
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Dallas, Texas 75246
Principal Investigator: James Strauss, MD
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Denver, Colorado 80218
Principal Investigator: Robert Jotte, MD
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Detroit, Michigan 48201
Principal Investigator: Hirva Mamdani, MD
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El Paso, Texas 79915
Principal Investigator: Panagiotis Valilis, MD
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Principal Investigator: Alexander Spira, MD
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
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Germantown, Tennessee 38138
Principal Investigator: Daniel Vanea, MD
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Houston, Texas 77024
Principal Investigator: Muffaddal Morkas, MD
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Jacksonville, Florida 32256
Principal Investigator: Miten Patel, MD
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Johnson City, New York 13790
Principal Investigator: Ronald Harris, MD
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Kansas City, Missouri 64132
Principal Investigator: Joseph Stilwill, MD
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McAllen, Texas 78503
Principal Investigator: Habib Ghaddar, MD
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5236 West University Drive
McKinney, Texas 75071
Principal Investigator: Monte Jones, MD
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Miami, Florida 33176
Principal Investigator: Federico Albrecht, MD
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Mobile, Alabama 36604
Principal Investigator: Sachin Pai, MD
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: David Spigel, MD
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Omaha, Nebraska 68114
Principal Investigator: Ralph Hauke, MD
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Orange City, Florida 32763
Principal Investigator: Santos Nair, MD
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Paramus, New Jersey 07652
Principal Investigator: Jin Lee, MD
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Pensacola, Florida 32503
Principal Investigator: Rami Owera, MD
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Pittsburgh, Pennsylvania 15232
Principal Investigator: Timothy Burns, MD
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Plano, Texas 75093
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Portland, Oregon 97213
Principal Investigator: Rachel Sanborn, MD
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Saint Louis, Missouri 63110
Principal Investigator: Siddartha Devarakonda, MD
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San Juan, 00927
Principal Investigator: Mirelis Acosta-Rivera, MD
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Tampa, Florida 33612
Principal Investigator: Jhanelle Gray, MD
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7695 South Research Drive
Tempe, Arizona 85284
Principal Investigator: Abhimanuy Ghose, MD
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Tyler, Texas 75702
Principal Investigator: Donald Richards, MD
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Vancouver, Washington 98684
Principal Investigator: David Smith, MD
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Whittier, California 90603
Principal Investigator: Merrill Shum, MD
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Winchester, Virginia 22601
Principal Investigator: William Houck, MD
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