Solid Tumor
Conditions
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
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
Interventions
BIOLOGICALFF21101
(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene)
Sponsors
Fujifilm Pharmaceuticals U.S.A., Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of radio-labeled FF21101 | 28 days | measured by number of patients with adverse events leading to discontinuation or number of patients with dose limiting toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients achieving overall response using Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of patients expressing CDH3 (human cadherin 3/P-cadherin) as a predictor of clinical activity | Single sample taken at enrollment | measurement of CDH3 expression |
Countries
United States
Outcome results
None listed