Clinical Study of WT2725 in Patients With Advanced Malignancies

NCT01621542 | Completed Phase 1 Results

• 1 other identifier: D8350004
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 6

Brief Summary

This clinical study is designed to evaluate the safety, immunogenicity and antitumor activity of WT2725. WT2725 will be administered to patients with advanced malignancies known to overexpress WT1

Conditions

Cancer

Keywords

Cancer; Vaccine; Oncology; Malignancies; Wilms' Tumor; WT1; Ovarian; Glioblastoma [GBM]; Acute myeloid leukemia [AML]

Outcome Measures

Primary Outcomes (2)

• Occurrence of Dose-limiting Toxicities and Adverse Events

  Evaluation of the safety and tolerability of WT2725 Dosing Emulsion based on the occurrence of DLT and AEs The safety and tolerability of WT2725 Dosing Emulsion will be evaluated based on the occurrence of DLT and AEs, and the findings from clinical laboratory tests, vital signs measurements, body weight measurements, and electrocardiogram (ECG) results. The incidence of DLT will be evaluated during the DLT Evaluation Period, which extends from the day of the first dose to just prior to the fifth dose of study drug (Days 1 to 29). No more than 4 doses of study drug will be administered during the DLT Evaluation Period.

  Up to 4 months

• Maximum Tolerated Dose (MTD) of WT2725 Based on the Evaluation of Dose-limiting Toxicity (DLT)

  Day 1 - Day 29

Secondary Outcomes (2)

• Antitumor Responses to WT2725 Based on the Immune-related Response Criteria (irRC)

  Day 1 - within 28 days after last dose

• Immune Response to WT2725

  Day 1 - within 28 days after last dose

Study Arms (1)

WT2725

EXPERIMENTAL

WT2725; injection

Biological: WT2725

Interventions

WT2725 BIOLOGICAL

WT2725 injection Study drug will be administered every 1-4 weeks

WT2725

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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(to the 4th power)/μl (≥ 5.0 x 10(to 4th power)/μl after stem cell transplant)
• Hemoglobin ≥ 9.0 g/dL
• Absolute lymphocyte count (ALC) ≥ 1,000/μl (≥ 500/μl after stem cell transplant) Note: After completion of dose escalation, patients with AML are not required to meet these hematologic criteria.
• 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 syndrome)
• 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 and/or, bone marrow biopsy, with 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.
• Patient or his or her legal representatives must give written informed consent and privacy authorization prior to participation in the study.

You may not qualify if:

• 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 4 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 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.
• Patient has received any of the following treatments within the specified timeframe prior to dosing:
• endocrine therapy, immunotherapy, transfusion, hematopoietic factors within 14 days prior to planned first dose of study drug (Note: After completion of dose escalation, patients with AML are not required to meet these hematologic criteria, eg. transfusions and hematopoietic growth factors.)
• 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 days)
• 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

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead
• Sumitomo Pharma Co., Ltd.: collaborator

Study Sites (6)

The University of Arizona Cancer Center - North Campus

Tucson, Arizona, 85719, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

The University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Fu S, Piccioni DE, Liu H, Lukas RV, Kesari S, Aregawi D, Hong DS, Yamaguchi K, Whicher K, Zhang Y, Chen YL, Poola N, Eddy J, Blum D. A phase I study of the WT2725 dosing emulsion in patients with advanced malignancies. Sci Rep. 2021 Nov 16;11(1):22355. doi: 10.1038/s41598-021-01707-3.

  PMID: 34785698 DERIVED

MeSH Terms

Conditions

Neoplasms; Wilms Tumor; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Myeloid; Leukemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: WT2725 Medical Director
• Organization: Sunovion Pharmaceuticals Inc.

clinicaltrialsdisclosure@sunovion.com

1-866-503-6351

Study Officials

• Vice President Clinical Development and Medical Affairs, MD

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 18, 2012
• Study Start: July 31, 2012
• Primary Completion: May 17, 2017
• Study Completion: May 17, 2017
• Last Updated: July 17, 2019
• Results First Posted: April 5, 2019

Record last verified: 2019-05

Locations

US (6)