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Initial Phase 1 Study of WT2725 in Patients With Advanced Solid Malignancies

Phase 1
18 Years
Open (Enrolling)

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Trial Information

Initial Phase 1 Study of WT2725 in Patients With Advanced Solid Malignancies

Treatment with other WT1 vaccines in clinical trials has shown evidence of immunogenicity
and clinical response in various malignancies.

This study will assist with determining which doses level(s) and route(s) of administration
to use in future clinical studies. In addition, this study will evaluate both clinical and
immunological response.

Inclusion Criteria:

- Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of
0, 1, or 2

- Patient must have one of the following histologically or cytologically documented
measurable (may be measureable by tumor markers only, such as quantitative RT-PCR for
WT1 transcript for AML, or CA-125 for ovarian carcinoma) advanced stage malignancies:
non-small cell lung, ovarian, glioblastoma, and AML (not including acute
promyelocytic leukemia), known to overexpress the WT1 protein.

- Patient must qualify with a study specific HLA typing assay.

- Haematological parameters:

- Absolute neutrophil count (ANC) ≥ 1,000/μl

- Platelet count ≥ 10.0x10^4/μl (≥ 5.0 x 10^4/μl after stem cell transplant)

- Hemoglobin ≥ 9.0 g/dL

- Absolute lymphocyte count (ALC) ≥ 1,000/μl (≥ 500/μl after stem cell transplant)

- Biochemical Parameters:

- serum creatinine of ≤ 1.5x upper limit of normal (ULN) for the reference lab.

- total bilirubin of ≤ 2.0 mg/dl (≤ 3.0 mg/dl for patients with known Gilbert's

- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times
the ULN for the reference lab

- Patient must have access to archival tumor tissue sample or agree to undergo biopsy
after study eligibility has been confirmed to obtain fresh sample for evaluation of
WT1 expression. In place of archival tumor tissue samples, subjects with AML should
have available a bone marrow aspirate, bone marrow biopsy, and/or RT-PCR for WT1
transcript performed before the first dose of study drug. Note: The archived tumor
tissue sample does not need to be delivered to the clinical site prior to enrollment
of the patient, however its availability should be confirmed through provision of the
accession number or other identification number

Exclusion Criteria:

- Patient with an extensively disseminated primary glioblastoma.

- Patient with symptomatic brain metastases, ie, not neurologically stable or requiring
treatment with corticosteroids, or central nervous system (CNS) leukemia.

- Patient with an infection requiring treatment with systemic antibiotics or antiviral
medication or has completed treatment for such an infection within 14 days prior to
planned initial dose of WT2725.

- Patient requiring systemic, pharmacologic doses of corticosteroids (equivalent to >
60 mg hydrocortisone/day or 2 mg dexamethasone/day). Replacement doses (equivalent to
≤ 5 mg prednisone/day), and topical, ophthalmic, and inhalation steroids are
permitted as needed.

- Patient has received any of the following treatments within the specified timeframe
prior to dosing:

- endocrine therapy, immunotherapy, transfusion, hematopoietic factors within 14

- chemotherapy including molecular-targeting therapy within 21 days (for
molecular-targeted agents that are not associated with myelosuppression or
immunosuppression, the minimum interval is 5 half-lives if that is less than 21

- surgery, radiation, or immunosuppressants within 28 days

- investigational drug within 28 days

- mitomycin-C or nitrosoureas within 42 days

- Patient with an unresolved ≥ Grade 2 AE from a previous antineoplastic treatment,
excluding alopecia.

- Pregnant or lactating women

- Patient with an autoimmune condition

- Patients with serious unstable medical illness

- Patient with pleural effusion, ascites, or pericardial fluid requiring drainage.

- Patient is a staff member of the sponsor or clinical site and is involved in the
conduct of the study or the relative of such a staff member

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Occurrence of dose-limiting toxicities and adverse events

Outcome Description:

Occurrence of dose-limiting toxicities and adverse events whilst on study treatment (Day 1) and ending 30 days after the last study treatment administration; an expected average of 4 months

Outcome Time Frame:

Up to 4 months

Safety Issue:


Principal Investigator

Head of Oncology, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2012

Completion Date:

October 2013

Related Keywords:

  • Cancer
  • Cancer
  • Vaccine
  • Oncology
  • Malignancies
  • Wilms' Tumor
  • WT1
  • Non-small cell lung cancer [NSCLC]
  • Ovarian
  • Glioblastoma [GBM]
  • Acute myeloid leukemia [AML]
  • Neoplasms



The University of Chicago Medical Center Chicago, Illinois  60637-1470
The University of Texas MD Anderson Cancer Center Houston, Texas  77030-4009
UC San Diego Moores Cancer Center La Jolla, California  92093
The University of Arizona Cancer Center - North Campus Tucson, Arizona  85719