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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02454010
Recruitment Status : Recruiting
First Posted : May 27, 2015
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Fujifilm Pharmaceuticals U.S.A., Inc.

Tracking Information
First Submitted Date  ICMJE May 4, 2015
First Posted Date  ICMJE May 27, 2015
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2015)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2015)
Safety and tolerability of 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 ]
Change History Complete list of historical versions of study NCT02454010 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2015)
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])
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2015)
Number of patients achieving complete 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])
Current Other Pre-specified Outcome Measures
 (submitted: May 21, 2015)
Number of patients expressing CDH3 (human cadherin 3/P-cadherin) as a predictor of clinical activity [ Time Frame: Single sample taken at enrollment ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Dose Escalation Study of Radio-labeled Antibody for the Treatment of Advanced Cancer
Official Title  ICMJE A Phase 1 Dose-escalation Study of Radio- Labeled Antibody, FF-21101(90Y) for the Treatment of Advanced Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor
Intervention  ICMJE Biological: FF21101
(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene)
Study Arms  ICMJE
  • Experimental: Lowest dose of FF-21101(90Y)
    In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101
    Intervention: Biological: FF21101
  • 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
    Intervention: Biological: FF21101
  • 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
    Intervention: Biological: FF21101
  • 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
    Intervention: Biological: FF21101
  • 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
    Intervention: Biological: FF21101
  • Experimental: Expansion Phase (Cohort 6), Ovarian
    In the expansion phase, subjects in this cohort will be diagnosed with epithelial ovarian, peritoneal or fallopian tube carcinoma and will receive a dose of 25 mCi/m2 FF-21101(90Y)
    Intervention: Biological: FF21101
  • Experimental: Expansion Phase (Cohort 7), Adv Tumors
    In the expansion phase, subjects in this cohort will be diagnosed with triple negative breast cancer (TNBC), head and neck squamous cell carcinoma (HNSCC), cholangiocarcinoma, pancreatic carcinoma, colorectal cancer and will receive a dose of 25 mCi/m2 FF-21101(90Y)
    Intervention: Biological: FF21101
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2015)
54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:
  • Negative serum pregnancy test
  • Ability to provide written informed consent
  • Expansion Phase: P-cadherin positive tumor expression

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Coordinator fphucontact@fujifilm.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02454010
Other Study ID Numbers  ICMJE FF21101US101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fujifilm Pharmaceuticals U.S.A., Inc.
Study Sponsor  ICMJE Fujifilm Pharmaceuticals U.S.A., Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fujifilm Pharmaceuticals U.S.A., Inc.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP