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A Dose Escalation Study of Radio-labeled Antibody for the Treatment of Advanced Cancer

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ClinicalTrials.gov Identifier: NCT02454010
Recruitment Status : Recruiting
First Posted : May 27, 2015
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Fujifilm Pharmaceuticals U.S.A., Inc.

Brief Summary:
The purpose of this study is to determine the safety and tolerability in subjects who receive FF-21101(111In) for dosimetry and FF-21101(90Y) for treatment of advanced solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor Biological: FF21101 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-escalation Study of Radio- Labeled Antibody, FF-21101(90Y) for the Treatment of Advanced Cancer
Study Start Date : January 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lowest dose of FF-21101(90Y)
In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101
Biological: FF21101
(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene)

Experimental: 2X Lowest dose of FF-21101(90Y)
In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 2X the lowest dose
Biological: FF21101
(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene)

Experimental: 3X Lowest dose of FF-21101(90Y)
In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 3X the lowest dose
Biological: FF21101
(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene)

Experimental: 4X Lowest dose of FF-21101(90Y)
In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 4X the lowest dose
Biological: FF21101
(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene)

Experimental: 5X Lowest dose of FF-21101(90Y)
In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 5X the lowest dose
Biological: FF21101
(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene)




Primary Outcome Measures :
  1. Safety and tolerability of radio-labeled FF21101 as measured by number of patients with adverse events leading to discontinuation or number of patients with dose limiting toxicity [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Number of patients achieving overall response using Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1) [ Time Frame: 8 weeks ]
    Overall response rates are defined as the number of patients achieving a best response of complete response [CR], partial response [PR], stable disease [SD], or progressive disease [PD])


Other Outcome Measures:
  1. Number of patients expressing CDH3 (human cadherin 3/P-cadherin) as a predictor of clinical activity [ Time Frame: Single sample taken at enrollment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females ≥ 18 years of age
  • Histologically or cytologically confirmed advanced solid tumor malignancy, refractory or relapsed from prior therapy, or for whom no alternative therapy is available
  • At least 4 weeks beyond the last chemotherapy (or ≥ 5 half-lives for targeted agents, whichever is shorter), radiotherapy, major surgery or experimental treatment and recovered from all acute toxicities (≤ Grade 1)
  • Archival tumor sample available, or be willing to undergo a fresh tumor biopsy, prior to study
  • At least one measurable disease site that meets target lesion requirements
  • Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2
  • Life expectancy of ≥ 3 months
  • Adequate hematologic parameters without ongoing transfusional support:
  • Hemoglobin (Hb) ≥ 10 g/dL
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9 cells/L
  • Platelets ≥ 150,000 x 10^6 cells/L
  • Adequate renal and hepatic function:
  • Creatinine ≤ 1.5x the upper limit of normal (ULN), or calculated creatinine clearance ≥ 60 mL/minute x 1.73 m^2 per the Cockcroft-Gault formula
  • Total bilirubin < 1.5 times ULN unless due to Gilbert's disease
  • ALT/AST ≤ 2.5 times ULN, or < 5 times ULN for subjects with liver metastases
  • QT interval corrected for rate (QTc) ≤ 480 msec on the electrocardiogram (ECG) obtained at Screening (average of 3 readings)
  • Negative serum pregnancy test
  • Ability to provide written informed consent

Exclusion Criteria:

  • Previous radioimmunotherapy. Previous antibody-based therapy is allowed as long as ≥ 28 days has elapsed from last dose to study treatment.
  • Prior radiation to > 30% of the red marrow or to maximal tolerable level for any organ
  • Serious cardiac condition within the last 6 months
  • Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of antimicrobials that are considered to be essential for care of the patient
  • History of retinal degenerative disease, history of uveitis, history of retinal vein occlusion (RVO), or any eye condition that would be considered a risk factor for RVO or has medically relevant abnormalities identified on screening ophthalmologic examination
  • Active central nervous system (CNS) malignant disease in subjects with a history of CNS malignancy. Subjects with stable, prior, or currently treated brain metastases are allowed.
  • Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV)
  • Known autoimmune disease
  • Active infection requiring intravenous (IV) antibiotic usage within the last week prior to the dosimetry portion of the study
  • Corticosteroid use within 2 weeks of study treatment
  • Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or confound the interpretation of study results
  • Pregnant or breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454010


Contacts
Contact: Study Coordinator 617-401-2243 fphucontact@fujifilm.com

Locations
United States, Texas
University of Texas M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Vivek Subbiah, MD       vsubbiah@mdanderson.org   
Principal Investigator: Vivek Subbiah, MD         
Sponsors and Collaborators
Fujifilm Pharmaceuticals U.S.A., Inc.

Responsible Party: Fujifilm Pharmaceuticals U.S.A., Inc.
ClinicalTrials.gov Identifier: NCT02454010     History of Changes
Other Study ID Numbers: FF21101US101
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Antibodies
Immunoglobulins
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs