Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02498665 : A Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced Malignancies
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion criteria:

1. Signed written informed consent must be obtained and documented according to
International Conference on Harmonisation (ICH) and local regulatory requirements

2. Patient has one of the following histologically or cytologically confirmed advanced
malignancies: acute myeloid leukemia (AML), myelodysplastic syndrome (MDS),
glioblastoma multiforme (GBM), melanoma, non-small cell lung cancer (NSCLC), ovarian
cancer, pancreatic cancer, sarcoma, renal cell carcinoma (RCC)

3. Patient must meet at least one of the following criteria: a. Progressed or recurrent
despite standard therapy, b. No standard therapy exists for this malignancy, c.
Patient is intolerant of standard therapy, d. Patient is not a candidate for standard
therapy, e. For AML and MDS patients: patient is not a candidate for allogeneic
hematopoietic stem cell transplantation, f, For sarcoma patients: f-1. Patient has
disease that is metastatic or unresectable, f-2. Patient with metastatic disease has
had at least one prior line of therapy for metastatic disease, f-3. No curative
multimodality options exist

4. Patients must be positive for at least one of the following human leukocyte antigens
(HLA): a. HLA-A*02:01, b. HLA-A*02:06, c. HLA-A*24:02

5. ? 18 years of age

6. For patients with solid tumors, one of the following must apply: a. Patient has
measurable disease as defined by the immune-related response criteria (irRC), b.
Patient has ovarian cancer and has disease evaluable by CA-125 only

7. For patients with solid tumors, the following criteria apply: a. Hemoglobin ? 9.0
g/dl, b. Absolute lymphocyte count ? 1.0 x 10^9/L, c. Absolute neutrophil count ? 1.5
x 10^9/L, d. Platelets ? 100.0 x 10^9/L

8. Patients with MDS must have been diagnosed as MDS by WHO (4th edition) or
French-American-British (FAB) classification

9. Patients with MDS must have failed to respond to, or progressed after, adequate
treatment with a hypomethylating agent (HMA), or had documented intolerance of an HMA,
and must have an International Prognostic Scoring System (IPSS) score ? 1.5

10. For patients with AML or MDS, patient must have white blood cell count (WBC) ?
50,000/mL. Hydroxyurea is allowed to achieve this change but must be discontinued a
minimum of five (5) days prior to baseline evaluation

11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

12. Male or female patients of child-producing potential must agree to use contraception
or avoidance of pregnancy measures during the study and for 180 days after the
DSP-7888 Dosing Emulsion dose

13. Females of childbearing potential must have a negative serum pregnancy test

14. Total bilirubin of ? 2.0 mg/dL (? 3.0 mg/dL for patients with known Gilbert's
syndrome)

15. Aspartate Aminotransferase (AST) ? 3.0x the upper limit of normal (ULN)

16. Alanine transaminase (ALT) < 3.0x the upper limit of normal (ULN)

17. Creatinine ? 2.0x ULN

18. Life expectancy ? 3 months

19. For patients with solid tumors, either archival tumor tissue must be available or
patient must consent to undergo on-study tumor biopsy before administration of first
dose

Exclusion Criteria:

1. Patient has an extensively disseminated primary glioblastoma

2. Patient has acute promyelocytic leukemia (APML)

3. For AML and MDS patients: patients with a dry tap on bone marrow aspiration during
screening

4. Patient has symptomatic brain metastases (i.e., metastases that are accompanied by
neurological symptoms or that require treatment with corticosteroids)

5. Patient has an infection requiring treatment with systemic antibiotics or antiviral
medication or has completed treatment for such an infection within 14 days prior to
planned first dose of study drug

6. Patient requires systemic, pharmacologic doses of corticosteroids (equivalent to >30
mg hydrocortisone/day) Note: Replacement doses (equivalent to ? 5 mg prednisone/day),
and topical, ophthalmic, and inhalation steroids are permitted as needed

7. Patient has a positive test for Hepatitis B surface antigen, Hepatitis C antibody,
human immunodeficiency virus HIV-1 or HIV-2 antibody, or has a history of a positive
result for hepatitis C virus (HCV) or HIV

8. Patient has received any of the following treatments within the specified timeframes:
a. Surgery, radiotherapy, chemotherapy (including molecular-targeted drugs): 4 weeks
(28 days), b. Immunosuppressants or cytokine formulations (excluding G-CSF): 4 weeks
(28 days), c. Endocrine therapy or immunotherapy (including biological response
modifier therapy): 2 weeks (14 days)

9. Patient has an unresolved ? Grade 2 adverse event (AE) from a previous antineoplastic
treatment, excluding alopecia and phlebitis

10. Patient has had surgery within 4 weeks prior to first dose

11. Woman who is pregnant or lactating or has a positive pregnancy test at screening. If a
woman has a positive pregnancy test, further evaluation may be conducted to rule out
ongoing pregnancy to allow the patient to be eligible

12. Patient has any concurrent autoimmune disease or has a history of chronic or recurrent
autoimmune disease; these include but are not limited to: multiple sclerosis, Grave's
disease, vasculitis, systemic lupus erythematosus, rheumatoid arthritis, systemic
sclerosis, myasthenia gravis, ankylosing spondylitis, Wegener's granulomatosis,
ulcerative colitis, Crohn's disease, psoriasis requiring systemic therapy, pemphigus,
temporal arteritis, dermatomyositis, Sjögren's syndrome, Goodpasture's syndrome,
interstitial pneumonitis, interstitial nephritis, or Henoch-Schönlein purpura

13. Patient has, in the opinion of the treating investigator, any intercurrent conditions
that could pose an undue medical hazard or interfere with the interpretation of the
study results; these conditions include, but not limited to: congestive heart failure
(New York Heart Association (NYHA) Class III or IV), unstable angina, cardiac
arrhythmia requiring treatment, recent (within the prior 6 months) myocardial
infarction, acute coronary syndrome or stroke, severe obstructive pulmonary disease,
hypertension requiring more than 2 medications for adequate control, or diabetes
mellitus with more than 2 episodes of ketoacidosis in the prior 12 months

14. Patient has Common Toxicity Criteria for Adverse Effects (CTCAE) v 4.0 grade ? 2
hemorrhage

15. Patient has pleural effusion, ascites, or pericardial fluid requiring drainage Note:
Patient who had drain removal ? 14 days prior to planned first dose of study drug and
has no sign of worsening is eligible

16. Patient has any other medical, psychiatric, or social condition, including substance
abuse, that in the opinion of the investigator would preclude compliance with the
requirements of this study

17. Patients with two or more active malignancies (synchronous multiple cancers, or
metachronous multiple cancers with a disease-free period of ? 5 years, with the
exception of carcinoma in situ, mucosal carcinoma, or other carcinomas that have been
curatively treated with local therapy)

18. Patient has had previous treatment with the study drug or other Wilms' tumor 1
(WT1)-related immune therapy

19. Patient has history of allergy to any oily drug products

20. Patient has a known hypersensitivity to any of the components of the study drug
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02498665      |      Link to official Clinicaltrials.gov listing
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