Clinical Trials /

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

NCT02454010

Description:

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.

Related Conditions:
  • Breast Carcinoma
  • Cholangiocarcinoma
  • Colorectal Carcinoma
  • Fallopian Tube Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Malignant Ovarian Epithelial Tumor
  • Malignant Solid Tumor
  • Pancreatic Carcinoma
  • Peritoneal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Dose Escalation Study of Radio-labeled Antibody for the Treatment of Advanced Cancer
  • Official Title: A Phase 1 Dose-escalation Study of Radio- Labeled Antibody, FF-21101(90Y) for the Treatment of Advanced Cancer

Clinical Trial IDs

  • ORG STUDY ID: FF21101US101
  • NCT ID: NCT02454010

Conditions

  • Solid Tumor

Interventions

DrugSynonymsArms
FF21101Lowest dose of FF-21101(90Y)

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Lowest dose of FF-21101(90Y)ExperimentalIn the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101
  • FF21101
2X Lowest dose of FF-21101(90Y)ExperimentalIn the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 2X the lowest dose
  • FF21101
3X Lowest dose of FF-21101(90Y)ExperimentalIn the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 3X the lowest dose
  • FF21101
4X Lowest dose of FF-21101(90Y)ExperimentalIn the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 4X the lowest dose
  • FF21101
5X Lowest dose of FF-21101(90Y)ExperimentalIn the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 5X the lowest dose
  • FF21101
Expansion Phase (Cohort 6), OvarianExperimentalIn 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)
  • FF21101
Expansion Phase (Cohort 7), Adv TumorsExperimentalIn 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)
  • FF21101

Eligibility 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:

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of patients achieving overall response using Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1)
Time Frame:8 weeks
Safety Issue:
Description: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])

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Fujifilm Pharmaceuticals U.S.A., Inc.

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