A Phase 1 interventional study of FF21101 in Solid Tumor, sponsored by Fujifilm Pharmaceuticals U.S.A., Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Fujifilm Pharmaceuticals U.S.A., Inc. · Phase 1, Interventional, and Treatment
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.
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. This is an open label study that will recruit approx 70 patients
Fujifilm Pharmaceuticals U.S.A., Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101
Biological: FF21101
In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 2X the lowest dose
Biological: FF21101
In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 3X the lowest dose
Biological: FF21101
In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 4X the lowest dose
Biological: FF21101
In the therapeutic phase subjects in this cohort will receive one dose of radiolabeled FF21101 that is 5X the lowest dose
Biological: FF21101
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)
Biological: FF21101
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)
Biological: FF21101
(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene)
Safety and tolerability of radio-labeled FF21101
measured by number of patients with adverse events leading to discontinuation or number of patients with dose limiting toxicity
Time frame: 28 days
Number of patients achieving overall response using Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1)
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 \[PD\])
Time frame: 8 weeks
Number of patients expressing CDH3 (human cadherin 3/P-cadherin) as a predictor of clinical activity
measurement of CDH3 expression
Time frame: Single sample taken at enrollment
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Fujifilm Pharmaceuticals U.S.A., Inc.