Clinical trial NCT02454010: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-27
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

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

Primary outcomes:
measure: Safety and tolerability of radio-labeled FF21101
timeFrame: 28 days
Secondary outcomes:
measure: Number of patients achieving overall response using Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1)
timeFrame: 8 weeks
Other outcomes:
measure: Number of patients expressing CDH3 (human cadherin 3/P-cadherin) as a predictor of clinical activity
timeFrame: Single sample taken at enrollment
Locations:
city: Atlanta
country: United States
facility: Winship Cancer Institute - Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University - Feinberg School of Medicine
state: Illinois
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Houston
country: United States
facility: University of Texas M.D. Anderson Cancer Center
state: Texas
Study officials:
References: