A Dose Escalation Study of Radio-labeled Antibody for the Treatment of Advanced Cancer
NCT ID: NCT02454010
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
73 participants
INTERVENTIONAL
2016-01-31
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lowest dose of FF-21101(90Y)
In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101
FF21101
(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene)
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
FF21101
(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene)
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
FF21101
(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene)
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
FF21101
(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene)
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
FF21101
(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene)
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)
FF21101
(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene)
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), biliary cancer (cholangiocarcinoma or gall bladder carcinoma), pancreatic carcinoma, colorectal cancer and will receive a dose of 25 mCi/m2 FF-21101(90Y)
FF21101
(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene)
Interventions
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FF21101
(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Fujifilm Pharmaceuticals U.S.A., Inc.
INDUSTRY
Responsible Party
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Locations
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Winship Cancer Institute - Emory University
Atlanta, Georgia, United States
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Mahalingam D, Owonikoko TK, Delpassand E, Mulcahy MF, Kalyan A, Ulahannan S, Cheung K, Izumi Y, Johansen M, Madden T, Shimoyama S, Subach RA, Suzuki T, Wages DS, Wheeler C, Richardson DL. A trial of radiolabeled antibody yttrium-90-FF-21101 for the treatment of advanced ovarian and other cancers. Cancer. 2025 Jan 1;131(1):e35680. doi: 10.1002/cncr.35680.
Other Identifiers
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FF21101US101
Identifier Type: -
Identifier Source: org_study_id
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